Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Michele Uda

Director General - ASSOGENERICI and IBG, Associazione Nazionale Industrie Farmaci Generici e Biosimilari IBG – Italian Biosimilar Group Chairman of the EMAC (European Market Access Committee of Medicines for Europe)

Graduated in Political Science from the International University LUISS Guido Carli in Rome, with a specialization in International Economics, after an initial experience in one of the largest Italian trade unions, he has successfully completed a full time MBA in International Business and Economics at "Mib School of Management" of Trieste. He then continued his career in the retail consumer sector at Ferrero Italy as Assistant Brand Manager for the Italian multinational company's core business and, later, at Colgate Palmolive Italy as a market and industry sales analyst in the Household Care division. He stepped into the healthcare sector joining Johnson & Johnson Medical where he was responsible for direct management of sales and marketing for the breast care line in Italy’s central and southern regions. From March 2007 he joined Assogenerici, the Italian Generic and Biosimilar Medicines Association, as “Pharmaceutical Economics & Policy Affairs Manager”, assuming direct responsibility of the Centre for Economics and Policy Analysis of the association. From April 2012 he has been appointed Director General of Assogenerici, keeping also the position as interim head of the Centre for Economics and Policy Analysis and the responsibility for international relations. Since 2014 is also managing IBG – Italian Biosimilars Group, the new industry body representing the biosimilar medicines industry within Assogenerici.He is also member of the Executive Board of Medicines for Europe (European Generic & Biosimilars Medicines Industry Association - formerly known as EGA) as Chairman of the EMAC (European Market Access Committee of Medicines for Europe).

Medicines for Europe

Prof. Helder Mota-Filipe

Associate Professor of Faculty of Pharmacy - University of Lisbon and Former Member of the Executive Board – National Authority of Medicines and Health Products (Infarmed I.P.), PT

Prof. Helder Mota-Filipe is a former Member of the Executive Board of Infarmed, I.P., National Authority of Medicines and Health Products, since 2005. He was in charge of the Inspection, Licensing and OMCL sectors (2005-2010). He is currently responsible for the human medicines, medical devices sectors and OMCL. He is currently the coordinator of Infarmed’s taskforce on falsified medicines. He is Associate Professor of Pharmacology and Therapeutics and responsible for the Socio-Pharmacy Department at the Faculty of Pharmacy of the University of Lisbon. He is also Principal Investigator in Pharmacology and Translational Research Unit at the iMED (Institute for Medicines) from University of Lisbon. He holds a PhD (1996) in Pharmacology and a PharmD (1990) from the Faculty of Pharmacy of the University of Lisbon. He is extensively involved in the development of research programs, such as Immunopharmacology and pharmacological modulation in ischemia-reperfusion and shock. He is a member of several Scientific Societies. He has been Member of the National Research Ethics Committee (2004) and EMA expert in Human Medicines Safety (2003). He has been member of CHMP (EMA) between June 2011-July 2012.

Medicines for Europe

Jaime Espín

Professor – Andalusian School of Public Health

Jaime Espín has a PhD in Economics (University of Granada), a Bachelor Degree in Law (University of Granada) and a Master in Health Economics (Andalusian School of Public Health). He has been Visiting Graduate Fellow in the Department of Economics in the University of California (UCSB); Visiting Professor in Duke University (Fuqua Business School) and Columbia University (Mailman School of Public Health); and Visiting Researcher in The University of Chicago. He has also attended to specialized training activities in the University of Harvard and Oxford. He is Professor in the Andalusian School of Public Health, where teaches and coordinates projects related to health economics, economic evaluations and pharmaceutical policies. Prof. Espín is an expert in European pharmaceutical policies and has been external advisor for the European Commission during the High Level Pharmaceutical Forum (Working Group on Pricing). He has been member of the Experts Committee on Pharmaceutical Policies of the Pan American Health Organization (PAHO/WHO) and member of the Pricing Policy Group of the WHO/HAI Project on Medicines Prices and Availability. He is co-author of the European Commission publication “Differences and Commonalities in pricing and reimbursement systems in Europe” and co-editor of the Pan America Health Organization (WHO/PAHO) publications “The access to high cost medicines in the Americas” and “Guideline for implementing generic strategies in Latin America and the Caribbean as a mechanism to improve access to medicines”.

Medicines for Europe

Giovanni Tafuri

Senior HTA Officer – Italian Medicines Agency (AIFA)

Giovanni Tafuri, PharmD, PhD, is a Senior HTA Officer at the Italian Medicines Agency. He is involved in HTA activities at the national level - providing technical support to the AIFA’s Committees for the definition of pricing and reimbursement schemes - and at the international level, representing AIFA at different networks on HTA. Before joining the Agency in 2006, he worked at the World Health Organization in Geneva (2002-2003), at the Mario Negri Institute for Pharmacological Research in Milan (2005-2006) and recently as a National Expert on Secondment at the Office of Scientific Advice of the European Medicines Agency in London (2015-2017) on HTA/EMA Parallel Scientific Advice. Giovanni Tafuri holds a Master of “International Health Care Management, Economics and Policy” from Bocconi University and a PhD in Pharmaceutical Policy and Regulation from Utrecht University, The Netherlands.

Medicines for Europe

Gergely Németh

Project Manager - National Health Insurance Fund of Hungary (OEP)

Gergely Németh graduated as a pharmacist in 2014 in Budapest. He has been working at the department in charge of reimbursement of pharmaceuticals of the Hungarian authority for health insurance. He has been involved in the planning and implementation of the Hungarian generic pricing policy since 2007 and participated in the development of sofwares supporting pricing and reimbursement of pharmaceuticals. He has been the project manager of the EURIPID project since its establishment in 2010. The EURIPID project is a non-profit initiative of the national competent authorities of Europe for the mutual sharing of pharmaceutical price information.

Medicines for Europe

Victor Lino Mendonça

Head of Policy and Market Access Europe – Mylan

Victor Lino Mendonça is the European Head of Policy & Market Access at Mylan and Board member of Medicines for Europe. Formerly he was the Head of Pharmaceutical Policy and Health Economics at the EGA – European Generic medicines Association. Before EGA he was also Advisor to the Executive Board of Infarmed - The Portuguese National Authority of Medicines and Health Products and Advisor to the Portuguese Health Secretary of State. Victor also worked as Product Manager at Boehringer Ingelheim Portugal and in the fast moving consumer goods area.

Medicines for Europe

Michael Fadus

Vice President of Compliance – Teva

Originally from the US, Michael has been living and working in Switzerland since 2001, and also became a Swiss citizen in 2011. Michael is a qualified attorney (California) and compliance professional with over 20 years of achievement working at law firms and companies in the US, Germany, and Switzerland, supporting major markets in Europe, the Middle East, and Africa. He has extensive compliance experience in the pharmaceutical, financial services, and automotive industries, whether in Fortune Global 500, mid-sized, or start-up companies. In addition to compliance and law, Michael has held roles in global HR and communications. He has a bachelor's degree from Boston University, a master's and law degrees from the University of Texas, and an MBA degree from Thunderbird. He is a native speaker of English and fluent in German. Michael currently chairs the working group on the Code of Conduct at Medicines for Europe. He is currently VP of Compliance at Teva Pharmaceuticals, handling global teams in specialty medicines and patient solutions, as well as managing a team of 28 compliance professionals in Europe.

Medicines for Europe

Ema Paulino

Professional Secretary - FIP Executive Committee and President Lisbon and South Branch - Portuguese Pharmaceutical Society

Ema Paulino is a practising community pharmacist at her own pharmacy in Portugal. She is currently accountable for the development and implementation of pharmaceutical services in a virtual chain of 300 pharmacies. She is President of the Lisbon and South Branch of the Portuguese Pharmaceutical Society and a member of its National Board, and represents this organisation at various international groups and organisations such as the Pharmaceutical Group of the European Union (PGEU) and the International Pharmaceutical Federation (FIP). Previously, she was a member of the Board of the National Association of Pharmacies. Currently Professional Secretary of FIP, Ema has previously been Chairperson and Project Coordinator of the Young Pharmacists' Group, a member of the FIP Programme Committee, and Secretary of the Community Pharmacy Section. Ema is a member of the Pharmaceutical Care Network Europe (PCNE). She was primary researcher in an international collaboration on identification of drug related problems in discharged patients, under the umbrella of the Stevenshof Institute for Pharmacy Practice Research (SIR) and European Society of Clinical Pharmacy (ESCP), The Netherlands, having won the Health Base Foundation Poster Award at the 30th ESCP Conference in Antwerp, Belgium, in 2001, for the poster and oral communication “Drug related problems among patients discharged from hospital”. Ema also conducted research on facilitators of practice change in community pharmacy. Ema’s leadership positions include Secretary General and Permanent Officer in The Netherlands for the European Pharmaceutical Students’ Association (EPSA) 2000-2001, President of the Portuguese Pharmacy Students’ Association (APEF) 1999-2000, Chairperson of Health Information, Promotion and Education Working Group of the local Students’ Association 1998-2000, Member of the National Department of Health Information, Promotion and Education of APEF 1998-1999, Member of the Representative Assembly of the Faculty of Pharmacy of Lisbon 1997-2000, and Vice –President of the Highschool Students’ Association 1992-1994. She contributes with a monthly column on international pharmacy-related issues in the Portuguese Pharmacy Magazine “Farmácia Distribuição”.

Medicines for Europe

Robert Andrew Johnstone, FRSA

Patient Advocate

Chair: Access Matters, Midstream, Board Member: European Forum for Good Clinical Practice (EFGCP), Health Quality Improvement Partnership (HQIP), International Foundation for Integrated Care (IFIC). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation.

Medicines for Europe

Christophe Lesguer

CCO, Chief Compliance Officer Europe – Mylan GmbH

Christophe is French Citizen, even he is leaving in Switzerland for the last 3 years. He is commercial and trade lawyer by education and a compliance professional with almost 15 years of experience in compliance for US registered pharma companies, both listed on the Fortune 500. He was regularly moving from legal duties, to compliance duties with a lot opportunities and is embracing the whole set of rules required in both modern and global companies. For the last three years he participated actively in the EGA Ethics group and became Chair of the Transparency group for Medicines for Europe and contributed to the effort on Transparency. He’s currently leading Mylan Europe Compliance team, over 30 countries+ for the last 5 years, with various professional background.

Medicines for Europe

Heikki Pälve

CEO – Finnish Medical Association

Heikki Pälve is the CEO of the Finnish Medical Association. He graduated 1980 and specialised to anaesthesia and intensive care 1987. He serve in the Turku University Hospital as an associate professor in anaesthesia and intensive care 1988 – 2005. He worked as an emergency helicopter physician for five years. He was the president of the FMA 2001 – 2003 and started as the CEO 2005. He has been the vice-president of the Finnish Academics Organisation 2005 – 07 and 2011 – 13. He served as the Vice-President of the European Physicians’ (CPME) 2012 – 2015 and has been a board member since 2005. Dr. Palve has been an active delegate of the World Medical Association (WMA) since 2001. He has been the Chair of the Medical Ethics Committee since 2013 and will finish his term this spring. He has participated to the workgroup for the renewal of the latest version of the Helsinki Declaration (DoH). He has been working on the ethical documents concerning the relationship between the medical profession and the pharma industry as a member of the FMA in Finland, CPME in the European level and WMA in the global arena. Heikki has been also politically active and has been member of the city council in Turku and member of the board of the University of Turku.

Medicines for Europe

John Gisborne

Managing Director and Senior Partner – FleishmanHillard Fishburn

John Gisborne heads the Healthcare Practice at FleishmanHillard Fishburn in London. He also co-leads the company’s European Healthcare Practice.
John is a biochemist by training but has spent twenty years at the forefront of healthcare communications, helping clients in the public and private sectors achieve a range of commercial, risk mitigation and health outcomes.
With a keen interest in the transformation of communications, John has led some of the most innovative digital and social campaigns of their kind. He is currently engaged in a range of content-led programs to support new articulations of value in pharma. John’s teams have also conceived and activated the World Health Organisation’s initiative to prevent microbial resistance and post-surgical infection, ‘Missing Type’ for NHS Blood and Transplant and Efpia’s Big Data For Better Outcomes project.
John was appointed Board Director and Trustee of the International FH Foundation in 2013.

Medicines for Europe

Aidan Fry

Editor – Generics Bulletin

Aidan Fry has been the editor of Generics bulletin, the business newsletter for the generic and biosimilar medicines industry, since August 2008. He had previously been the deputy editor of Generics bulletin since the newsletter’s inception in 2003, having also spent five years working on its sister publication, OTC bulletin. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.

Medicines for Europe

Paul Tunnah

CEO and Founder – Pharmaphorum

Dr Paul Tunnah founded pharmaphorum in 2009, which has rapidly evolved and developed its services to drive better communication, connection and collaboration between the pharmaceutical industry and other healthcare stakeholders. He is a recognised author, speaker and moderator with a passion for helping organisations tell authentic stories that resonate, co-create solutions and unlock the power of digital and social media in connecting with customers and understanding markets. Prior to this, Dr Tunnah attained a BA in Biochemistry and DPhil in Biological Sciences, where he conducted research into novel anticancer agents, from Oxford University, before working in commercial consulting for Datamonitor, IMS Health and SmartAnalyst.

Medicines for Europe

Laetitia Tonel

Head of Communications – Mylan Europe

Laetitia Tonel is Head of Communications for Mylan Europe. She has held this position since 2012, having served for more than 10 years as a PR Director for the Fast-Moving Consumer Goods industry (Kellogg’s, Danone, Pernod Ricard). Laetitia is in charge of raising Mylan awareness across Europe as well as promoting key brands, generic medicines and biosimilars using both media and social media. She has developed the digital footprint of Mylan across Europe. Laetitia is the chair of Medicines for Europe Communication Group. Laetitia holds a Master’s degree of Law (France, Bordeaux) together with a Master’s degree in Communications - CELSA (France, Paris). She is a member of the European Association of Communication Directors in Brussels (EACD).

Medicines for Europe

Chris Lewis

Senior Manager External Communications – Sandoz Global Communications

Chris is a corporate communications professional with broad international experience, particularly in the pharmaceutical and energy sectors.
He has been with Sandoz / Novartis for over 10 years, in roles ranging from Biopharma communications lead to US communications lead, as well as media relations and crisis management. He is currently responsible for financial and strategic communications within the Sandoz Global Communications team.
Chris began his career as a journalist in the UK and Switzerland and subsequently managed a global PR mandate for clients in the energy industry, before joining Novartis.
He holds an MA from Corpus Christi, Cambridge, and an MBA from Henley Management College. He is married with one daughter and his hobbies include travel, photography, scuba diving and mountain hiking.

Medicines for Europe

James Duggan

Principal Medical Writer – 90TEN/IGBA Communications Project

James has worked within medical communications for over six and a half years. During this time he has worked across several therapy areas, which include a number of biological treatments. In addition, James plays a hybrid role bringing science and digital learning to life. His focus is on learning theory and bringing the science to life, utilising storytelling to enhance knowledge retention. James also uses data visualisation to help improve comprehension of complex scientific data.
Prior to working in medical communications, James completed a PhD in Cell Biophysics at Nottingham University where he examined the interaction of molecules with cell membrane, and a Postdoctoral placement at the Institute of Ophthalmology, UCL, where he worked on glaucoma and ocular drug delivery. James is part of the team that has been involved in developing the IGBA’s latest educational materials.

Medicines for Europe

Evan O'Connell

Communications and Public Affairs Specialist – Aspect Consulting

Evan is a communications and public affairs specialist. He leads Aspect Consulting's public affairs and media activities in France, while also working on EU, UK and international PR and lobbying projects and campaigns for Aspect. He has worked for corporates and trade associations across a wide range of sectors including: food and drink, chemicals and life sciences, extraction and energy, sport, and telecommunications; as well as non¬profits and governments including the government of Georgia and Open Society Foundations.
Prior to joining Aspect, Evan was responsible for communications and public affairs for a major climate change research project in Paris, was a research assistant to a U.S. Congressman on Capitol Hill, and worked in publishing and business intelligence. A New Yorker by birth and a Londoner and Dubliner by upbringing, Evan has lived, worked and studied on three continents. A graduate of Sciences Po Paris, he holds a degree in Eastern European Studies and a master’s in Finance. In addition to his native English, he speaks near-native French, as well as Dutch, German and Czech.

Medicines for Europe

Sergio Napolitano

Legal and External Relations Director – Medicines for Europe

Sergio Napolitano is Legal and External Relations Director at Medicines for Europe. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on “The Role of the Congress in Shaping the US Trade Policy”. He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).

Medicines for Europe

Alan Sheppard

Principal, Global Generics and Biosimilars, Thought Leadership - QuintilesIMS

Alan has over 45 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations. In his role at QuintilesIMS he is responsible for developing services and insights for the industry and its associations on generic medicines and biosimilars through a combination of consulting, information and market analyses. Previous positions include Executive VP, Europe Generics, Dr Reddy’s; VP Global Corporate Strategy, PLIVA; European Marketing Director, Medeva; General Manager, Rhône-Poulenc Rorer UK; General Manager, Mérieux UK; and management roles with Servier and SKF. Alan is also an expert witness on patent litigation issues and their commercial impact, working with leading international law firms. Other roles have included Chairman, Technical Advisory Group, Access to Medicines Foundation; guest BRAPP lecturer, University of Wales working in the medicines faculty specialising in pharmaceutical marketing and clinical trials; a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board; Fellow, Chartered Institute of Management; Fellow, International Doctors’ Association and Member, Chartered Institute of Marketing.

Medicines for Europe

Alejandro Ollé

Partner and Co-founder - Galenicum

Alejandro Ollé, partner and co-founder of Galenicum, is the company’s responsible for B2C business, and has established operations in Latin America and South East Asian markets.
Prior to the founding of Galenicum, Alejandro worked as a consultant with Cluster Consulting where he was involved in international projects in Brazil, France, India and the MENA region.
Alejandro has a degree in Industrial Engineering and MSc. Applied Chemical Engineering by Institut Français du Pétrole.

Medicines for Europe

David Jauch

Senior Manager Global Regulatory Affairs, Government Relations – Fresenius Kabi

David M. Jauch is responsible for Government Relations within Global Regulatory Affairs of Fresenius Kabi. He is the Chairman of the Global Policy and Market Committee, Member of the Board of Medicines for Europe as well as a member of the Trade Committee of IGBA (International Generics and Biosimilar Association). Also, David is a member of the Regulatory Committee of the German Pharmaceutical Industry Association (BPI). David’s studied Business Administration at the University of Stuttgart in Germany, Tongji University in Shanghai, China and Seoul National University in Korea and holds an Executive Master in Business Management of Leeds University Business School in the UK.

Medicines for Europe

Oleh Syarkevych

Business Development Director – Farmak

At present Oleh Syarkevych works as a Business Development Director. Oleh is responsible for establishing business relations with foreign partners, expanding Farmak product portfolio through the In-licensing, introduction of the Company's products through Out-licensing partners to new markets.
Business Development Department headed by Oleh initiated and supported implementation of GMP EU, ISO 13485, FDA standards and drafting of documentation in CTD EU, ACTD formats.
Oleh Syarkevych represents Farmak at Medicines for Europe. He is also an outside expert of Ukrainian Association of Pharmaceutical Manufacturers.
Oleh worked in different areas of pharmaceutical business: pharmaceutical, scientific, industrial, and he also served as Chairman of the Board for Halychpharm.
Oleh Syarkevych is the author of about 50 scientific papers and over 20 patents. Oleh was awarded Certificates of Merit of the Ministry of Healthcare of Ukraine, and diplomas of the Kyiv City State Administration, medal and diploma of the Cabinet of Ministers.
In 1997 he earned his MBA degree from the Lviv Institute of Management.
Oleh served internship in the USA and Germany at pharmaceutical enterprises Parke-Davice Warner Lambert and Parke-Davis Gödecke.
Oleh graduated from the Lviv Medical Institute (at present known as Danylo Halytsky Lviv National Medical University). He earned his PhD degree in Pharmaceutics.

Medicines for Europe

Natalia Matting

Lawyer - DG Trade, European Commission

Natalia Matting is a trade negotiator in the European Commission, working mainly on regulatory barriers to trade impacting various industrial sectors, including in the pharmaceutical area. She has over 10 years of experience working in the European institutions on a number of policy areas. Before joining the institutions, she worked as an associate for Baker & McKenzie. Natalia studied law in Hungary and in the UK, and holds an LL.M. of European and Comparative Law from the University of Maastricht.

Medicines for Europe

Koen Nauwelaerts

Quality and Regulatory Manager – Medicines for Europe

Koen Nauwelaerts studied pharmacy at the University of Leuven, Belgium, holds a PhD in pharmaceutical sciences and obtained an MBA degree from Vlerick Business School. In 2015 he joined the EGA as manager Quality and Regulatory Affairs. Before joining Medicines for Europe, Koen was active in both QA and Regulatory Affairs roles at MSD (Merck Sharp and Dohme).

Medicines for Europe

Jacek Glinka

President – Medicines for Europe

Jacek Glinka is the President of Medicines for Europe and the President of the European Region for Mylan, one of the world’s leading global pharmaceutical companies which is dedicated to providing the world’s 7 billion people access to high quality medicine. Mylan is present in 35 countries in the European region and in approximately 165 countries and territories globally. Mr. Glinka has joined Mylan from the Polpharma Group, where he served as chief executive officer from 2003 to 2006 and from 2009 to 2013. During his tenure, he led the transformation of Polpharma from a local player into a leading pharmaceutical company in central and Eastern Europe, the Caucasus and central Asia. Prior to that, Mr. Glinka was a managing director at Spectra Services, where he oversaw a number of acquisitions and restructurings, including the acquisition and integration of Akrihin into Polpharma Group. He began his professional career as a strategic management consultant with firms including Deloitte & Touche and A.T. Kearney.

Medicines for Europe

Prof. Maria do Céu Machado

President – INFARMED

Maria do Céu Machado was appointed, through Resolution of the Council of Ministers published on June 2, president of the Board of Infarmed - National Authority of Medicine and Health Products.
The new Head was the Director of the Department of Pediatrics of the Hospital of Santa Maria and Professor of Medicine at the Faculty of Medicine of the University of Lisbon. Was also Vice-President of the National Health Council and Member of the National Ethics Council for Life Sciences. Between 2006 and 2011 she was the High Commissioner for Health.
She was honored as Grand Officer of the Order of Merit in 2010 and received the Gold Medal of the Ministry of Health in 2012.

Medicines for Europe

Adrian van den Hoven

Director General – Medicines for Europe

Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, to foster market access for generic, biosimilar and value added medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries. Prior to joining Medicines for Europe, Adrian van den Hoven was Deputy-Director General of BUSINESSEUROPE where he was responsible for the International Relations department, covering trade negotiations and bilateral relations, and the Industry department, covering industrial, energy, environmental and research policy. He previously worked as an International Relations researcher and an adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor). He obtained his doctorate in Political Science from the University of Nice, France in 2000.

Medicines for Europe

Rabia Khan

Health Division – OECD

Rabia Khan is a health policy analyst at the OECD, working mainly in the pharmaceutical area. She has worked as an epidemiologist in government and academic institutions in New Zealand, Australia and the United Kingdom with over 15 years of experience in the health sector. She is a Fellow of the UK Faculty of Public Health. Her main interests are in improving health and reducing health inequalities though better use of technology, information and evidence.

Medicines for Europe

Christa Cepuch

Pharmacist Coordinator - MSF Access Campaign

Christa Cepuch is a pharmacist with a Master of Public Health. She has recently joined the Médecins sans Frontières (MSF) Access Campaign as Pharmacist Coordinator. The Campaign’s purpose is to push for access to, and the development of life-saving and life prolonging medicines, diagnostic tests and vaccines for patients in MSF programs and beyond.

Medicines for Europe

Alex Harris

CEO – International Health Partners

Alex is a political consultant turned humanitarian, now using his advisory experience to advocate for increased private sector engagement and collaboration in improving access to medicine in frontier markets and fragile states. Prior to joining IHP, he worked as a lobbyist to the pharmaceutical industry, foreign governments and a diverse range of companies who required expert knowledge of the UK and European political systems. During his ten years at IHP, Alex has also served as Head of Corporate Partnerships and Director of Operations. IHP’s mission is to help those without access to medicine in the developing world by coordinating the safe and responsible donation of medical products from the healthcare industry across Europe.

Medicines for Europe

Pierluigi Antonelli

Head of Western Europe – Sandoz

Pierluigi Antonelli, in Sandoz since August 2015, is Head of Western Europe for Sandoz International and Member of the Sandoz Executive Committee. Pierluigi started his career as entrepreneur in the automotive business before joining McKinsey, where he worked both in the US and Italy. He then spent the last sixteen years in the Pharmaceutical/Healthcare industry, starting his career at Bristol-Myers Squibb where he held several executive roles in different geographies (Italy, Portugal, US, France and Switzerland). After moving in 2011 to Merck & Co in Italy, he successfully acted as Senior Vice President in Italy and Europe/Canada Fertility Lead over a 1.2 billion USD business with more than 1.000 employees. Pierluigi joined Medicines for Europe in 2016 as Vice President and Treasurer. An Italian national, Pierluigi holds an MBA from Kellogg Graduate School of Management and a degree in Business and Economics from L.U.I.S.S. University.

Medicines for Europe

Jim Keon

President – Canadian Generic Pharmaceutical Association (CGPA) and President - Biosimilars Canada

Jim Keon is President of the Canadian Generic Pharmaceutical Association (CGPA), and President of Biosimilars Canada organizations representing Canada’s generic and biosimilar pharmaceutical sectors.
Jim graduated with an M.A. in Economics from Queen’s University, and has more than 20 years experience in the pharmaceutical sector.
Jim has served as President of the CGPA since 1998 and was named the founding President of Biosimilars Canada in January 2015. Prior to joining CGPA in 1994 he held senior positions in the federal government and was directly involved in international trade negotiations for NAFTA and the WTO, as well as Canada’s inter-provincial trade negotiations.
Jim is Past Chair of the International Generic and Biosimilar Medicines Association (IGBA), which is committed to promoting the interests of generic and biosimilar medicines around the world. He is currently Chair of the IGBA International Trade Committee.

Medicines for Europe

Kyozo Inari

Executive Corporate Officer, External Affairs Department - Sawai Pharmaceutical Co.,Ltd. and Chair International Affairs Committee - JGA

Since 2008, he has served as head of external affairs department at Sawai Pharmaceutical Co.,Ltd and he is also the current chair of the international affairs committee of JGA.
Before joining the Sawai, he had been working for the Ministry of Health and Welfare since 1974, where he accumulated experience in the field of product review, GLP, GCP, drug pricing and control of narcotics. He also had work experience at the National Cancer Center Hospital and PMDA (Pharmaceutical and Medical Devices Agency).
He is a Pharmacist, graduated from the master course of Kyoto University (Faculty of Pharmacy) in 1974.

Medicines for Europe

John McCullough

VP Commercial Generics Europe & Global In-line Portfolio Management – Teva

I’ve worked in the industry since 1996 across both Innovator, Parallel Trade and more recently in Teva for the last 1O years in the Generic space, where I current hold the position of Vice President for Commercial Portfolio Europe and globally look after the optimisation strategies that allow Teva to offer a wide range of generic medicines in keeping with our top and bottom line objectives.
My experience working in and out of country across sales and marketing roles, business development and M&A, and portfolio has allowed me the privilege of experiencing market access challenges and creating solutions at all levels. Strategic choices on geography, size of entity, operational capabilities, commercial go to market strategies, effective price and reimbursement, and knowledge of market trends, are at the heart of what I do. If strategic choice is the heart, then Execution is the life blood and without it the heart is useless. So with that said I’m responsible to ensure delivery of strategies with our stakeholders, so not only enabling market access for generics, but for me the most important word “sustainability” for both our patients, customers and our corporate objectives.

Medicines for Europe

Tony Mauro

Chief Commercial Officer – Mylan

Anthony (Tony) Mauro is Mylan’s Chief Commercial Officer, overseeing commercial businesses around the world. Tony is responsible for leading and executing Mylan’s global commercial strategy for the company’s more than 7,500 marketed products in more than 165 countries and territories. Mauro has been with Mylan, a leading manufacturer of generic pharmaceuticals, for more than 20 years serving in several capacities. Most recently, he served as president of North America, successfully leading the company’s largest commercial business. Prior to that role, Mauro served as president of Mylan Pharmaceuticals Inc., the company's flagship generics division in the U.S.; chief operating officer of Mylan Pharmaceuticals ULC in Canada; vice president of North America Strategic Development; and vice president of North America Sales. In 2012 and 2013, Mauro served as chairman of the board of directors for the U.S. Generic Pharmaceutical Association (GPhA), which represents the world's leading generic drug manufacturers and suppliers. Prior to that he served two consecutive terms as vice chairman of the board for GPhA, now known as the Association for Accessible Medicines.

Medicines for Europe

Gian Mario Baccalini

President – Aschimfarma and Chair – European Fine Chemicals Group

President of Aschimfarma since 2011 and Chairman of the PAC (Pharmaceutical Activities Committee) / EFCG (European Fine Chemical Group Cefic) since 2009. He began his experience in the 70s as Production Manager and Plant Manager in Pierrel, a diversified Italian company in all areas of health. He gained experience in handling different plants with production of APIs for synthesis and fermentation, final dosage injectable and not, OTC, medical devices. In this company in the 80s reached the position of General Manager and Vice President, developing all the business activities with significant improvement in marketing, business development and sales though the worldwide market. During this years he had important experience in USA managing local facilities and commercial relationsship with big pharma. Later, after a brief experience in a new biotechnology french company, with a group of entrepreneurs, acquired Alfa Chemicals which later became PFC, with acquisitions in the United States and in Italy. In PFC he was Managing Director. The Group was sold to Honeywell USA in 2000.with a very high multiple of EBITDA, after five years of the important growth performing excellent result in revenues and profitability. In the early 2000s he began his experience in the Association, holding the position of President of Aschimfarma from 2003 to 2009 and being also a member of the Board of Federchimica. In 2006 he founded a research center for technology development which was sold in 2016. During this period of time he was very active collaborating with private equity group in merger and acquisition. He was Chairman of the Group Euticals in the period 2013-2014 during the period of integration needed after 2 important acquisitions.

Medicines for Europe

Dinesh Dua

Vice Chairman - Pharmaceuticals Export Promotion Council of India

Dr. Dinesh Dua, is currently the Chief Executive Officer & Whole Time Director of M/S Nectar Life sciences Ltd.-a US$ 310 Mio.(Rs. 2000 Crs.) Niche company in life sciences.
Immediately prior to NLL, he was Managing Director of Akorn India Pvt. Ltd.,a 100% subsidiary of US MNC,Akorn Inc., which was a sequel to a very successful 6 year stint at M/S Nectar Lifesciences Ltd. As CEO & Director on Board between 2007 & 2012.
Mr. Dua holds a Masters in Business Management (M.B.A.)-1979 batch from Harvard Business School promoted, Indian Institute of Management Ahmedabad.
He has over 38 years of professional experience across varied industries in leadership positions such as Healthcare, Pharmaceuticals & Biologicals, Petrochemicals and Consumer goods, having worked in multinational organizations such as Hoechst (Sanofi Aventis), Berger Paints, and large Indian Corporates like Reliance, Jubilant Organosys, Zydus Cadila Healthcare & as President of Wockhardt Ltd’s International & Biotechnology Strategic Business Unit (SBU).
He is currently North India Chairman for Higher Education for Confederation of Indian Industry (CII) & is also immediate Past Chairman of CII, Chandigarh Council, Vice Chairman, Pharmaceuticals Export Promotion Council (Pharmexcil)-A part of Ministry Of Commerce, Govt. of India, Member Executive Council, Bulk Drug Manufacturers Association (BDMA),Advisor for International Business for Federation of Pharmaceuticals Entrepreneurs (FOPE) & is also a visiting faculty to leading & reputed Management institutes in India.

Medicines for Europe

Satoshi Kawamura

Senior Vice President – Nipro Pharma Corporation

Satoshi Kawamura is the senior vice president of Nipro Pharma Corporation, which is the largest CDMO in Japan,and he is currently supervising the Business Development Division. He has more than 20 years’ experience in pharmaceutical manufacturing field, starting his career as a production engineer and set up 7 manufacturing lines for sterile injectables such as dual chamber bags (PLDB®), prefilled syringes and lyophilized vials. On occasion of establishing Odate plant in 2002, which is one of the mother plants of Nipro Pharma, he was assigned as the Plant Director and successfully led the starting-up of another 13 lines, including dual chamber prefilled syringes.
In 2012, he was assigned also as General Director of Nipro Pharma Vietnam Co.,Ltd, which is the first overseas subsidiary of Nipro Pharma and successfully started commercial operation on original schedule.

Medicines for Europe

Jody Cox

Vice President Federal and International Affairs, Canadian Generic Pharmaceutical Association and Vice President, Biosimilars Canada

Jody has been responsible for the CGPA’s intellectual property, legal affairs and trade files since 2007. She was active on behalf of the generic and biosimilar medicines industries in both the negotiations for a Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union and the Trans-Pacific Partnership (TPP) negotiations, and is currently focused on the Canadian implementation of CETA. She coordinates the CGPA’s legal activities, which has included several successful interventions in pharmaceutical patent matters at the Supreme Court of Canada. In addition to her work with CGPA, Jody is Vice President of Biosimilars Canada, the voice of Canada’s biosimilar medicines industry, where she has been responsible for scientific regulatory affairs, legal affairs and market access since its inception in January 2015. She is also an active member of the International Generic and Biosimilar Medicines Association (IGBA), and serves as Secretariat to the IGBA International Trade Committee and is a member of the IGBA Biosimilars Committee.

Medicines for Europe

Marc-Alexander Mahl

Executive Vice President Business Unit Generic Drugs – Fresenius Kabi and Chair Hospital Working Group – Medicines for Europe

Marc-Alexander Mahl is heading since 2011 the global Business Unit Generic Drugs & Standard Solutions at Fresenius Kabi. Since he joined Fresenius in 2001 Marc had multiple global and regional management positions in Medical Devices, Marketing and the Generics & Standard Solutions business of Fresenius Kabi with the responsibility to create a globally balanced, profitable and sustainably growing generic drugs business for Fresenius Kabi. Marc´s mission outside of Fresenius Kabi is to make the European generics business again more attractive for pharmaceutical companies and local investments in manufacturing. Being a physician by training Marc completed in 2001 his specialization in transfusion medicine / blood banking. In 2008 Marc received his eMBA degree from INSEAD (Fontainebleau / Singapore).

Medicines for Europe

Annie Pannelay

Principal – The Economist Intelligence Unit

Annie Pannelay leads the healthcare consulting practice of the EIU. Her role is global. The healthcare vertical includes the policy analysis services to the industry, as well as more specialised services, including value consulting. She helps her clients navigate the challenges presented by the current environment, including the increasing need for clinical and economic evidence required by healthcare policy-makers, insurers and payers. Prior to joining the Economist, Annie held roles with various stakeholders in the healthcare industry. Her experience include working as resident hospital pharmacist (Nice CHU, France), working for the pharmaceutical industry in market insights and business planning roles, as well as healthcare banking. Most recently before joining the Economist Intelligence Unit, Annie worked as strategy consultant, advising top pharmaceutical companies. She also currently is the vice-president of the UK Chapter for ESSEC Alumni, the international network of ESSEC Business School, organising professional events for the alumni community in the UK. She has worked in Europe, Hong Kong and New York. Annie holds a Doctor of Pharmacy Degree from Montpellier University, a BSc in biologic and medical sciences from Montpellier University and an MBA from ESSEC business school in Paris. She is fluent in English and French.

Medicines for Europe

Maggie Dolan

Regional Pharmacy Procurement Specialist – NHS Commercial Solutions Surrey

Maggie Dolan obtained her pharmacy degree from Heriot Watt University, Edinburgh in 1978 and her clinical pharmacy diploma from Strathclyde University, Glasgow in 1991. She has spent most of her career in the NHS in the hospital pharmacy sector but did work for a short time in the pharmaceutical industry with MCP Pharmaceuticals assisting in the Medicines Information and New Product Registration functions. She has been responsible for pharmacy services in both the adult and paediatric settings having been Chief Pharmacist of Edinburgh Sick Children’s NHS Trust and West Lothian NHS Trust .Over the last 15 years she has developed a keen interest in medicine logistics, procurement and contracting in the NHS both as Pharmacy Advisor to National Procurement National Services Scotland and currently as Regional Procurement Specialist South East Coast, England. She is a strong advocate of the delivery of Medicine Optimisation as part of routine practice and chairs the NHS Biosimilars group and the National Purchasing and Distribution Interest Group. She believes the appropriate adoption of biologics including biosimilars is essential for the NHS and patients.

Medicines for Europe

Aida Batista

Director of Professional Development – European Association of Hospital Pharmacists (EAHP)

Degree in Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon (1987) Specialization in Hospital Pharmacy (1994) Postgraduate Course in Management and Leading of Health Services, Faculty of Economics, University of Porto (2006) PADIS - Advanced Management Program for Healthcare Organizations, AESE Busibness School (2016) Hospital Pharmacist since 1987 Senior Pharmacist, Centro Hospitalar de Vila Nova de Gaia (CHVNG/E) (2003-2013) Member of Drug and Therapeutic Committee, CHVNG/E, since 2004. Director of Pharmacy Department, CHVNG/E, since July 2013 Board Member of a Union of civil servants: STE – Sindicato dos Quadros Técnicos do Estado (1990-1992). Board Member of the Portuguese Association of Hospital Pharmacists - APFH (2002-2005) President of APFH, (2008- January 2015) Delegate to the General Assembly of the European Association of Hospital Pharmacists - EAHP (2009-2010; 2015) EAHP Board Member, Director of Professional Development

Medicines for Europe

Marcel T.M. van Raaij, PhD

Director Ministry of Health – The Netherlands

Marcel van Raaij studied Medical Biology at the State University of Leiden (The Netherlands) and received his PhD in Physiology at the same university. After his PhD he moved to the field of toxicological risk assessment stationed at the National Institute of Public Health and Environment (RIVM). He was active in various international working groups and commissions (EU,WHO, OECD, US EPA) dealing with regulatory frameworks on e.g. pesticides, biocides and accidental exposures to (industrial) chemicals. After leading the Center for Integrated Risk Assessment for a number of years at RIVM, he became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety at RIVM dealing with environmental policy and physical safety including preparedness and response activities. In October 2014 Marcel van Raaij was appointed as Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tissues and cells including organ donation policy. The Netherlands presented a new Pharma policy in January 2016.

Medicines for Europe

Dominik Tomek

Board Member – European Patients Forum (EPF)

Dr. Dominik Tomek, PharmD., PhD., MPH, 1956, has experience in public and hospital pharmacies, government administration and regulatory agency incl. oncology hospital, Ministry of Health and Health Insurance. He was elected as director in the ISPOR Board of Directors for the term 2014 – 2016 and serves as a chair of education committee of ISPOR CEE Network. Dr. Tomek served for many years in the Drug Committee of State Institute for Drug Control, Pricing Committee of Ministry of Finance and Reimbursement Committee of Ministry of Health. He is teaching at the Faculty of Medicine, Slovak medical university, Bratislava, Slovakia. He is vice president and scientific advisor to the Association for the Protection of Patient Rights in Slovak republic for second term and Board Member of the European Patients Forum in Brussels for second term.

Medicines for Europe

Yi-Yun (April) Wang

Legal Manager - Yung Shin Pharm. Ind. Co., Ltd. and Chair, International Affairs Committee – Taiwan Generic Pharmaceutical Association (TGPA)

Yi-Yun (April) Wang is the current chair of the International Affairs Committee of TGPA. Since 2008, she has served as the manager of the legal department at Yung Shin Pharm. Ind. Co., Ltd. where she oversees the company’s legal matters, including litigation, Paragraph IV matters, contracts, legal analysis and mergers & acquisitions. Ms. Wang has received extensive training in the areas of IP and technology management. She was selected by the Taiwan Department of Industrial Technology to participate in intellectual property and technology management training programs sponsored by the George Washington University Law School, the Asia-Pacific Legal Institute and the University of California, and also in IP training focused on European IP law in cooperation with the Max Planck Institute and the European Patent Office. She has an LL.M. at the Soochow University School of Law, and also holds both a B.S. & M.S. in Nutrition and Health Science from Taipei Medical University’s College of Public Health and Nutrition.

Medicines for Europe

David R. Gaugh, R.Ph.

Senior Vice President for Sciences and Regulatory Affairs - Association for Accessible Medicines (AAM)

David Gaugh has over 25 years of leadership experience in the Healthcare and Pharmaceutical business. He has been employed by AAM (formerly GPhA) since February 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the US Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.Prior to Bedford Laboratories, David was Senior Director, Pharmacy Contracting and Marketing at VHA/ Novation (now Vizient). And prior to VHA/Novation, David was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO. David is a registered Pharmacist and has been engaged in several board-level pharmacy-related activities such as; the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.

Medicines for Europe

Sabine Kopp, Dr

Group Lead, Medicines Quality Assurance – WHO

Sabine Kopp is Group Lead of WHO’s Medicines Quality Assurance and has worked for the World Health Organization (WHO) since 1986. She was, inter alia, Secretary for the International Nonproprietary Names (INN) Programme, Acting Team Coordinator for Quality Assurance and Safety of Medicines, Programme Manager for the Quality Assurance and the Anticounterfeiting programmes, Acting Secretary of the International Medical Products Anti-Counter-feiting Taskforce (IMPACT) and was also actively involved in the WHO Member State mechanism on Substandard/ spurious/ falsely-labelled/falsified/counterfeit medical products medical products. Sabine Kopp is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and is responsible for the coordination of WHO's activities related to the development and maintenance of international guidelines, GXPs, standards and norms related to Medicines Quality Assurance, i.e. the normative work related to Medicines Quality Assurance within WHO, spanning from development and manufacturing to the distribution and supply of the medicines.

Medicines for Europe

Brendan Cuddy

Head of Manufacturing and Quality Compliance, Committees & Inspections Department - European Medicines Agency (EMA)

Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002. Brendan is currently Head of Manufacturing and Quality Compliance Service and he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). The Manufacturing and Quality Compliance Service is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party. The Service plays a key role in collaborating and communicating with international partners on setting and recognising GMP standards, making better use of inspectional resources and exchanging information on availability of already authorised medicines. Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

Medicines for Europe

Nuala Calnan

Senior Associate Compliance Practice - Lachman Consultant Services, Inc.

Nuala Calnan, Ph.D., is a Senior Associate in the Compliance Practice at Lachman Consultants delivering consultancy services to the pharmaceutical, biopharmaceutical, medical devices and diagnostics industries. With 25 years’ industry experience, Dr. Calnan has authored international industry standards and guidance documents on validation, qualification and risk-based verification approaches, including the ASTM E2500:07 verification standard. She continues to publish in the field of excellence for the biopharmaceutical industry.
In the course of her career, she has led multi-disciplinary front-line teams supporting day-to-day manufacturing operations and new facility start-ups. She specializes in transforming compliance-led quality management systems by enabling organizations to focus on delivering quality excellence through the integration of cultural excellence, knowledge excellence and operational excellence strategies.
Dr. Calnan is also an Adjunct Research Fellow in Regulatory Science at the Dublin Institute of Technology. Her own research includes examining quality metrics for the US Food and Drug Administration (FDA) and quality defects and product recalls for the Irish Health Products Regulatory Authority (HPRA).
Recent Publications
 Knowledge Excellence in the Biopharmaceutical Industry, Taylor and Francis – CRC Press (June, 2017)
 Cultural Excellence Report, ISPE (April, 2017)
Professional Affiliations
 ISPE: Co- Chair of the Quality Culture Team;
 Core Team Member of ISPE Quality Metrics Team;
 Co-chair of PQLI Task Team for Knowledge Management

Medicines for Europe

Mechthild Sander

Qualified Person - Alfred E. Tiefenbacher (AET)

Working at AET since 1999, starting with regulatory affairs establishing a Quality department and system at AET and working as Qualified Person at AET. Since 2016 working part-time on specific projects in Quality and GMP questions and as Qualified Person. Before joining AET, Mechthild Sander worked since 1985 in Quality Control in several pharmaceutical companies, such as Desitin Arzneimittel GmbH, D-Hamburg, Rottendorf GmbH, D-Ennigerloh and Bela Pharm, D-Vechta.

Medicines for Europe

Christoph Stoller

SVP Chief Operating Officer GGM Europe - Teva Pharmaceuticals Inc. and Vice President - Medicines for Europe

Christoph Stoller is Teva’s Chief Operating Officer Europe. Most recently he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe, in that role he was also responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph serves as Vice President of Medicines for Europe and chairs the sector group on Value Added Medicines. He has been working for Teva Europe since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland.

Medicines for Europe

Mondher Toumi

Professor – University of Aix-Marseille

Professor Mondher Toumi is M.D. by training, M.Sc. in Biostatistics, and in Biological Sciences (option pharmacology) and Ph.D. in Economic Sciences. Mondher Toumi is Professor of Public Health at Aix-Marseille University.
After working for 12 years as Research Manager in the department of pharmacology at the University of Marseille, he joined the Public Health Department in 1993. In 1995 he entered the pharmaceutical industry and worked there for 13 years.
Mondher Toumi was appointed Global Vice President at Lundbeck A/S in charge of health economics, outcome research, pricing, market access, epidemiology, risk management, governmental affairs and competitive intelligence.
In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making.
In February 2009 he was appointed Professor at Lyon I University in the Department of Decision Sciences and Health Policies. The same year, he was appointed Director of the Chair of Public Health and Market Access. He launched the first European University Diploma of Market Access (EMAUD) an international course already followed by almost 400 students. Additionally, he recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment. Since 2009, he also chairs the Annual Market Access Day, a purely academic event. He is Editor in Chief of the Journal of Market Access and Health Policy (JMAHP) a PubMed indexed journal.
Since September 2014, he joined the research unit EA3279 of the public health department, at Aix-Marseille University (France) as full Professor. Mondher Toumi is also visiting Professor at Beijing University (Third Hospital).
He is a recognized expert in health economics and an authority on market access and risk management. He has more than 200 scientific publications and oral communications, and has contributed to several books. He recently published a book Introduction to Market Access for Pharmaceuticals (CRC Press).

Medicines for Europe

Sampreet Ramachandra

Director Global Portfolio and Strategic Marketing – Fresenius Kabi

Sampreet Ramachandra is with Fresenius Kabi since 2009 and currently serves as the Director of Strategy after handling different positions in India, UK & Germany in the past. His passion is for an ever-better healthcare across the world & keen interest in the role of pharmaceuticals in Fresenius Kabi's shared mission of caring for life. He holds degrees in Engineering, Health Economics & an MBA and is an alumnus of the London School of Economics & Indian Institute of Technology.

Medicines for Europe

Antonio Vaz Carneiro

Head - Centre for Evidence-Based Medicine (CEMBE), Faculty of Medicine of the University of Lisbon

With 40 years of professional experience in Portugal and the US, António Vaz Carneiro is a Medical Doctor holding specialist degrees in Internal Medicine, Nephrology and Clinical Pharmacology. He is also a Professor at the Faculty of Medicine, University of Lisbon (FMUL) where he directs the Center for Evidence Based Medicine, having several other educational and scientific responsibilities in the FMUL. He is a Clinical Researcher with special interest in the areas of secondary research (systematic reviews and meta-analyses), methodologies of translation of knowledge into practice and systems to support clinical, administration / management, health policy decision-making and to increase health literacy of citizens. Prof. Vaz Carneiro is the Head of Cochrane Portugal.

Medicines for Europe

Hanan Sboul

Secretary General – Jordanian Association of Pharmaceutical Manufacturers

After more than 10 years of work at Jordan Food & Drug Administration JFDA, Hanan has joined the Jordanian Association of Pharmaceutical Manufacturers JAPM back in 2003 as a Secretary General. She utilized her regulatory expertise in assessment of generic dossiers & quality control, her knowledge on IPR and her skills in lobbying & advocacy to represent the Jordanian generic industry in Jordan and internationally. Hanan is a member of USP Council Governance Committee for 2015 – 2020 Cycle and was a member of the USP Council of Convention for 2010- 2015 Cycle. She is also a member of the Steering Committee for Jordan Pharmaceutical Center of Excellence, a Board member of the Fund for Employment, Technical, Vocational Education & Training, a member of the Steering Committee of Medicine Transparency Alliance. Hanan is also a member of Scientific Research Support Fund & an ex member of the Hashemite University Board of Trustees. Hanan received her MBA from Jordan University and her B.A in pharmacy from Yarmouk University in Jordan in 1986.

Medicines for Europe

Carol Lynch

Head Global Biosimilars – Sandoz

Carol Lynch is the Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. She leads a 3000+ person organization focused on the development, manufacturing and commercialization of biosimilars and oncology injectables. She is also responsible for Sandoz’s biopharmaceutical contract manufacturing business. Lynch has more than 25 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz in 2014, Lynch held several Commercial and Development leadership positions in Novartis Pharmaceuticals both globally and in country organizations, including the United States. She is a member of the Sandoz Executive Committee and Chair of the Biosimilar Medicines Group.

Medicines for Europe

Catarina Nobre

President – EPSA

Catarina is 24 years old, finishing her Master’s degree at the Faculty of Pharmacy of the University of Lisbon. Since the beginning of her academic life, she had a high interest in the associative segment and started to be an active member of the local students’ association, participating in the most diverse organising committees for students’ events. With the increasing intercultural curiosity and potential discovered in the European Pharmaceutical Students’ Association (EPSA), Catarina partook in the Reception Committee of the EPSA Summer University 2015 is Lisbon, as Partnership Officer and Treasurer. Soon after, she decided to successfully run for EPSA Treasurer. After experiencing two consecutive mandates as EPSA Treasurer and as an Executive member (2014-2015 and 2015-2016), in April 2016, she applied to be EPSA President 2016-2017. Currently, she holds the position of EPSA President, managing a Team of 28 individuals and representing over 160.000 pharmacy students across Europe.

Medicines for Europe

Elisabeth Stampa

CEO – Medichem

Born in Barcelona, Spain, in 1967.
Elisabeth graduated in Pharmacy at the Universidad de Barcelona, Spain in 1990 and after one year as Scientific Consultant she continued her studies to get a Master in Business Administration at ESADE Business School, Barcelona, Spain with a student exchange program in Cranfield Business School, UK.
She started her career in Laboratorios Esteve SA. Three years after she joined the family owned business (Medichem SA and Combino Pharm SL) devoted to Active Pharmaceutical Ingredients (APIs) and Finished Dosage Products (FDFs) and served as Managing Director at Combino Pharm SA. In year 2000 she moved to the Corporate structure of the business as General Manger. After the divestment of part of the business in 2015 she became Executive Chairwoman and since July 2016 acts as CEO for Medichem SA.
Elisabeth participated in the negotiations representing the European Active Ingredients industry in the GDUFA II negotiating round.

Medicines for Europe

Suzette Kox, M.Sc., Pharm.

Senior Director International - Biosimilar Medicines Group Sector Group - Medicines for Europe and Chair Biosimilars Committee - International Generic and Biosimilar Medicines Association (IGBA)

Suzette Kox was nominated Senior Director International in October 2015, following 14 years in the position of EGA’s Senior Director Scientific Affairs and Coordinator of the Biosimilar Medicines Group (formerly called European Biosimilars Group), a sector group of Medicines for Europe (formerly EGA). She is also Chairperson of the Biosimilars Committee of the International Generic and Biosimilar Medicines Association (IGBA) where she is leading currently a global biosimilars communication project.
Suzette has been involved with biosimilar medicines in Europe since 2001 and has been until 2015, the Programme Director of the association’s annual Biosimilars Conference, which has become over the years the main annual gathering of the world’s key biosimilars regulators and experts. In her positions, she has given numerous presentations on generic and biosimilar medicines at conferences around the world.
Previously she worked for 10 years in regulatory affairs and management for the German pharmaceutical company ratiopharm (now Teva) and was Chair of the EGA Regulatory & Scientific Affairs Committee and member of the EGA Board and Executive Committee. She was also a visiting faculty member of the School for International Training: Department Development Studies and Public Health in Geneva. Before joining the generic and biosimilar medicines industries in 1991, she followed a hospital and retail pharmacy career. Along with a degree in pharmacy (Paris), Suzette holds a postgraduate diploma in anatomy-pathology (Cochin Port Royal, Paris) and is multilingual.

Medicines for Europe

Belinda Wood

CEO – Generic and Biosimilar Medicines Association (GBMA), Australia and Vice-Chair of the IGBA Biosimilars Committee

Belinda Wood is the CEO of the Generic and Biosimilar Medicines Association (GBMA), the Australian association representing companies that manufacture, supply and export generic and biosimilar medicines. Belinda has over 22 years’ experience in the pharmaceutical industry and was appointed CEO in December 2014 having been the organisation’s Policy Director from 2012. Belinda was pivotal in negotiations leading to the signing of a Strategic Agreement with the Australian Government in May 2015 that recognises the important role of generic medicines and biosimilars in PBS affordability. Belinda holds a BMedSc in Pharmacology and is a graduate of the Australian Institute of Company Directors. She proudly contributes to the work of the IGBA Trade Committee, and is the deputy-chair of the IGBA Biosimilars Committee.

Medicines for Europe

Paulo Lilaia

President – Apogen

Paulo Lilaia is currently the president of the Portuguese Generic and Biosimilar Medicines Association (APOGEN) since 2008. APOGEN, founded in 2003, represents generic and biosimilar medicines companies and is responsible for communicating to stakeholders on behalf of members.
He holds a Masters in Business Administration and an Executive MBA, both from ISCTE Business School, having previously made his education at ISPA, Institute of Applied Psychology, and ESSA, School of Health Alcoitão. His career also includes, among others, training in management and marketing at INSEAD in France and Ashridge University in England.
Since July 2010, he is the Chief Executive Officer of Generis Farmacêutica, S.A. and previously was Director General of Ratiopharm Portugal between 2004 and 2010.

Medicines for Europe

José Inácio Faria

MEP – EPP Portugal

Member of the European Parliament since 2014 and member of several Committees among which the Committee on the Environment, Public Health and Food Safety. He is a lawyer, graduated in Portugal, and has been legal adviser for the Lisbon City Council.
From 2007 to 2009 he has been Chair of the National Jurisdiction Council of the Partido da Terra (Earth Party) and from 2009 to 2011 Secretary General of the Earth Party. He is also a member of the MEPs Interest Group “European Patients’ Rights & Cross-Border Healthcare”.

Medicines for Europe

John Hodgson

Executive Director, Editor In Vivo - Informa Pharma Intelligence

John Hodgson is Executive Editor at Informa, working for Scrip Intelligence and In Vivo. He has been a commentator on the biotechnology and healthcare industries for over 35 years, first as a science editor (Trends in Biotechnology, Nature Biotechnology) and then as a consultant (clients included the European Commission and UK government, venture-backed start-ups, multinationals in pharmaceuticals and agriculture, and industry associations). He currently explores disconnections between science and industry, between announcements and delivery, and between words and numbers.

Medicines for Europe

Enrique Ordieres

President of Laboratorios Cinfa and Infarco

Enrique Ordieres is a pharmacist and an advocate of the role played by these health professionals and the pharmaceutical industry; he has been working in this sector for 27 years. For over a decade he has chaired Cinfa, the leading laboratory in terms of amount of medicines dispensed in Spanish pharmacies, which is presently undergoing a diversification and globalization process. He also chairs the parent company, Infarco, which likewise encompasses other health companies, including Cinfa Biotech, 3P Biopharmaceuticals and Cyndea Pharma, developers and manufacturers of chemical and biotechnological drugs. Graduated in Pharmacy, he has an MBA and a postgraduate degree in Dermo-Pharmacy, among other additional academic training. He has been a pharmacy owner and has chaired the Pharmacists’ Professional Association of Vizcaya and of the Basque Country, as well as being co-author of various books and publications, and a regular lecturer at various congresses and conferences.

Medicines for Europe

Jeremy B. Desai

CEO – Apotex Inc.

Jeremy was born in London, UK and gained a Pharmacy degree in 1981 followed by a PhD in 1985. He has spent over 30 years in progressively senior roles in the pharmaceutical industry. In 2014 he was appointed as CEO Apotex based in Toronto, Canada, having joined the company in 2003 as the Global Head of R&D.

Medicines for Europe

Frances Cloud, CFA

Founder – Pharmacloud

Frances Cloud runs her own consultancy, Pharmacloud, which is focused on generics and off-patent brands. She founded Pharmacloud after a 20+ year career in the City, as a pharmaceutical analyst and an M&A adviser. Pharmacloud’s activities span commercial due diligence, market mapping and market entry strategies, market modelling, strategic consulting and M&A support. Clients range from big pharma to small start-ups and also encompass a broad range of private equity funds. Recent transactions for which Pharmacloud has provided commercial due diligence include Doc Generici (Italy), Ethypharm (France), Martindale (UK, working for Ethypharm) and Stada (Germany, working for Cinven).
Frances Cloud holds a BA in Biochemistry from Magdalen College, Oxford and is a CFA charterholder.

Medicines for Europe

Randall Stanicky, CFA

Managing Director - RBC Capital Markets

Randall Stanicky, CFA, is a Managing Director at RBC Capital Markets. Randall has been head the RBC Specialty Pharmaceuticals team for the past three years covering global generic manufacturers and specialty therapeutic providers. He is a regular Wall Street speaker at international conferences and ranked Runner-up (RU) in the “Institutional Investor” poll this past year. Prior to RBC, he spent most of his career at Goldman Sachs, where as a Vice President in Global Investment Research, his coverage spanned specialty pharmaceuticals, drug distribution, pharmacy benefit managers, healthcare technology and the contract research organization sectors. Randall also served as a Managing Director at Canaccord Genuity and prior to joining the sell-side he was an analyst at Citigroup Global Asset Management assisting in the investment recommendations of healthcare stocks. He is also an active member and head of the audit committee of the Board of the Director of the Children’s Tumor Foundation and previous Board member of TherapeuticsMD (TXMD). Randall lives in New York City with his wife and two children.

Medicines for Europe

Simon Goeller, Dr.

Partner, Mckinsey & Company

Simon Goeller is a Partner based in Munich and the global leader of McKinsey's Generics Practice. Since joining McKinsey in 2002, Simon has worked for clients around the world on topics related to generics, branded generics, LOE management, pharma distribution and retail. He serves pharmacos, wholesalers, retailers/pharmacy chains, and PE firms. His recent experiences include global strategy and portfolio definition for a leading player in Branded Generics, pricing and market access efforts for various off-patent pharma and branded companies, field force optimization effort for generics player in Eastern Europe, post-merger integration and brand positioning for retail pharmacy chain, global strategic purchasing strategy for major U.S. healthcare company, lead and expert on various private equity and industry due diligences in healthcare, marketing & sales excellence programs for pharma companies across Europe, Japan, and the US, including specialty players and dermatology, definition of one of the largest global healthcare provider partnerships, consumer health and branded generics growth strategies globally. Prior to joining McKinsey, Simon obtained a B.A and M.Sc in Economics and Management Research from the University of Oxford (U.K.), and a PhD in Health Care Economics from the University of Giessen (Germany).

Medicines for Europe

Rafael Enrique Maciel Martínez

President – AMEGI

Surgeon, graduated from Universidad Nacional Autónoma de México (UNAM), Degree in Pharmacology. With experience in the pharmaceutical industry for more than 30 years, companies such as The Upjohn company, Boehringer Manheimm. Roche-Biotechnology and the last 14 years in the field of generics with Apotex. Throughout the period he has held positions such as; Director General, Marketing and Sales, Research and development, as well as medical and regulatory areas. President of the Mexican Association of Generics AMEGI since 2007.

Medicines for Europe

Jean Mina

Associate Partner – McKinsey & Company

Jean Mina is an Associate Partner in the Geneva office of McKinsey and Company.
Jean is a leader of McKinsey Pharmaceuticals and Medical practice.
In particular, Jean drives McKinsey’s knowledge effort and client activity in emerging markets globally, with focus on Sub-Saharan and North Africa. Jean has extensively served leading pharmaceuticals companies across emerging markets on topics ranging from growth strategy and market entry, to go-to-market and broader business model innovation. Recent experience include emerging markets market entry, strategic planning for large pharma multinational, generics growth strategy in Africa, business model innovation in Latin America, Asia and Africa. Jean is a published author on pharma in emerging markets. He holds an MBA from Columbia University in New York, USA and an engineering degree from the University of Toulouse in France.

Medicines for Europe

Abdallah Mazahreh

Marketing Director/MENA & Emerging Markets – Pharma International Company

Holds a Bachelor in Pharmacy (1995) and an MBA degree (2002) from University of Jordan. Mr. Mazahreh started his 22 years’ experience since 1995 and has taken different strategic positions within the different multinational companies. He led local, regional and global functions in sales, business development, launch, market access and marketing. He worked for companies as GlaxoSmithKline Middle East Pharmaceuticals (1995-2002), Ferring Middle East Pharmaceuticals(2003-2009) and Bayer EMEA HealthCare Pharmaceuticals(2010-2014). In 2015 he moved to generic industry as the Corporate Marketing Director for Dar Al Dawa a generic company in the MENA region. As from January 2016, Mr. Mazahreh joined Pharma International Company, a rising star and a fast growing generic company in the MENA region as Director of Marketing heading the marketing function in the MENA and emerging markets.
Mr. Mazahreh has extensive cross cultural experience and markets understanding within the MENA and emerging markets region in addition to different global markets exposure. Skilled in effective sales management, strategic marketing management, launch and market access excellence, leadership and cross cultural team management.
Additionally, Mr. Mazahreh has extensive certifications and business trainings from different international institutions such as Management Center Europe, Japan Leadership Academy, KPMG International, Vlerick Business School, UK Institute of Sales and Marketing and others.

Medicines for Europe

Vivian Frittelli

CEO – NAPM

Vivian Frittelli has been involved in the pharmaceutical industry for over a quarter of a century. He headed Hoffmann La Roche’s Marketing and Sales Division in South Africa before doing a stint as Country Manager for Roche in Saudi Arabia. Upon returning to South Africa he was appointed Regional Director of an NGO, The Smile Train, where he worked to provide subsidized surgeries for children with Cleft lips and palates throughout Southern Africa. Thereafter, he joined Sandoz Pharmaceuticals to establish their oncology division in the Country. Three years ago he joined the National Association of Pharmaceutical Manufacturers as the Chief Executive. The Association represents generic and biosimilar medicines manufacturers and is responsible for communicating to stakeholders and lobbying with government on behalf of members. He is a member of the management committee of the IGBA.

Medicines for Europe

Dilip G Shah

Secretary General – IPA

Mr. Dilip G. Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 50 years of varied experience in the pharmaceutical industry. He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicines and several other international meetings and conferences. He was a Member of the official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Member of the Expert Review Committee of Access to Medicine (ATM) Index (www.atmindex.org); Member of the CPhI International Advisory Board; Member of the Board of Advisors of Pharmabiz.com (Weekly); and Member of Task Forces and Expert Groups constituted by the Government of India for accelerating growth of the Indian pharmaceutical industry. He was Chair of the International Generic Pharma- ceutical Alliance (IGPA) for two terms (2005-07) and (2010-11). Mr. Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd, Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group (www.vision-india.com), a firm specialized in strategic planning. Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years.

Medicines for Europe

Keh Song Hock

Executive Director – Malaysian Organisation of Pharmaceutical Industries (MOPI)

Graduated with a Bachelor of Pharmacy degree from the University of Singapore in 1971. Served 30 years in the Malaysian public sector, 27 years with the Ministry of Health and 3 years on secondment as a Senior Research Officer with the National Scientific Council for Research & Development, Ministry of Science, Technology & Environment. Held various positions when in the Ministry of Health including Secretary to the Pharmacy Board, Medicines Advertisements Board, and the Ministry of Health Drug Formulary Panel. Retired as the Deputy Director of Pharmaceutical Services, Ministry of Health Malaysia in 2001. Joined the Pharmaceutical Association of Malaysia (PhAMA), an organization representing the innovative medicines industry and served as its Executive Director for 12 years from 2001 to 2012 and as advisor in 2013. Joined the Malaysian Organisation of Pharmaceutical Industries (MOPI), an organization representing the generics and biosimilars manufacturers in 2014 as Executive Director and has held this position since.

Medicines for Europe

Talgat Nurgozhin MD, PhD, DSc, Professor

Director of Center for Life Sciences – “National Laboratory “Astana”, Nazarbayev University

Nurgozhin Talgat graduated in 1992 from the Military Medical faculty at the Tomsk State Medical University. In 2002 he trained in Pharmacoepidemiology at the Boston University School of Public Health (USA) and participated in a seminar on ‘Medicine Policy Issues for Developing Countries’ organized by the World Health Organization and the Boston University School of Public Health in Beirut, Lebanon. He also did a continuing education course on ‘Economics, Policy and Administration’ in the Department of Medical Administration of the University of Virginia Commonwealth, Richmond, USA (2007).
From 2006-2009 he worked as a Vice Rector of the organizational and economic work, Almaty State Institute of Postgraduate Medical Education and was Professor of the Clinical Pharmacology Department. From 2009 -2011 he worked as a Managing Director of the National Medical Holding and since 2009 he has been the Deputy Director of the Healthcare Development Institute. From 2011 to 2015 he has been working at the "Nazarbayev University", Center for Life Sciences, as a Head of the Department of the Translational Medicine, Healthy Ageing and Global Health and Director of the Institute of experimental and clinical Pharmacology. Since 2016 - Director of Center for Life Sciences, “National Laboratory Astana” at Nazarbayev University. Professor Nurgozhin T participated in the development of the National Health Reform Program "Densaulyk" for 2016-2019 on the reform of the pharmaceutical health sector. He contributed to the development of the first Lists of Essential Medicines for Kazakhstan. Professor Nurgozhin introduced formulary system into practical health care to control the proper use of medicines. Participated in the development and creation of the Kazakh National Formulary and he is the editor-in-chief. Professor Nurgozhin member of the National Formulary Committee of the Ministry of Health and Social Welfare. Since 2016, he is the member of the commission to unite the quality of medical services at the Ministry of Health. Vice-President ISPOR Kazakhstan Regional Chapter.
For special merits in the health protection of the population of the Republic of Kazakhstan he was given an award pin as a grade «A» person in Health Affairs of the Republic of Kazakhstan (2005). He was also honored with a badge “For distinguished contribution to the development of health of the Republic of Kazakhstan” (2011). For achievements in the field of science he received an award pin «For merits in Science Development for the Republic of Kazakhstan» (2011, 2015). Prof. T. Nurgozhin is the author of more than 150 scientific works, seven monographs and eight predpatents and is a member of the editorial boards of the Consilium journal (2004), Big Guide of Medicines of the Moscow publishing house «Geotar-Media» (2011) and the Russian Pharmacoeconomics journal.

Medicines for Europe

Gillian Woollett

Senior Vice President and Head FDA Policy and Regulatory Strategy Practice - Avalere Health

Gillian Woollett, M.A., D.Phil., SVP at Avalere, leads the FDA Policy and Regulatory Strategy Practice at Avalere, an advisory services firm of over 250 people that supports clients throughout the healthcare system, from patients to biopharma companies and payers/providers. At Avalere she provides the “prequel” of scientific and technical expertise that supports drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful in the public and private reimbursement world. She launched the FDA Practice in 2012. Dr. Woollett and her Team translate into practical action all aspects of regulatory engagement strategy and policy development relevant to commercial success for multiple multi-national clients. Concurrently, she created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with over 20 now having used this stepping stone to transition careers.
Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel & Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at PhRMA, where her group led, for example, on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity). At both trade associations, Dr. Woollett managed the interface between bio/pharma companies and the US Government in a manner that enabled their collective ability to expedite product development but without invoking any concerns of anticompetitive activity. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biological weapons issues.
Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as domestic, regulatory and scientific issues. She has been an appointee on Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She is currently represents biotechnology on the Material Technical Advisory Committee (MTAC) at the Department of Commerce (requiring a Secret Security clearance), and chairs the Biotech Work Group that addresses export controls and the Biological Weapons Convention, among other issues. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT), and on the Board of the Pharmaceutical Education Research Institute (PERI).
Gillian earned her B.A., M.A. in the Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the UK. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. She is well published in the peer reviewed literature.

Medicines for Europe

Suzanne McGurn

Assistant Deputy Minister and Executive Officer – Ontario Public Drug Programs

Suzanne is the Assistant Deputy Minister (ADM) and Executive Officer (EO) for the Ontario Public Drug Programs. In this role, she oversees one of the largest drug programs in North America, providing access to prescription medications for nearly 4 million Ontarians. Her position immerses her in the conversation about pharmaceuticals from all perspectives – patients, clinicians, manufacturers (generics/brands/biosimilars), pharmacists and pharmacy sector, research, innovation, health system and the list goes on.
Suzanne also plays a significant leadership role within the pan-Canadian Pharmaceutical Alliance (pCPA). Through its efforts the pCPA is bringing improved value to the publicly funded drug plans across Canada, harnessing the negotiating power of 14 participating jurisdictions with its emphasis on not only affordability but also greater consistency in access and appropriateness. In addition to the pCPA work, the Ontario Public Drug Programs is an important part of Ontario’s broader efforts to address other key public policy challenges through initiatives such as: the pharmacy naloxone program, reduction in access to high strength opioids, the patch for patch program, access to medications for MAID (Medical Assistance in Dying), expansion of access to Hepatitis C drugs and increased access to medications for low income seniors. All of these initiatives having launched during the past year.
Suzanne brings over 30 years of experience in the health care environment to bear in the work she does – half of that time spent in various clinical and management positions as a nurse and half of the time spent in public service. Her education reflects a similar split as a graduate of Queen’s University with both a Bachelor of Nursing Sciences and a Masters of Public Administration.
In addition to her enthusiastic approach to her current role, she is also passionate about her family and enjoys her weekend trek home to Tamworth, a small farming community north of Napanee and time spent with her family including two grandchildren.

Medicines for Europe

Hiroyuki Sakamaki, MBA, Dr Med Sci.

Professor – Tokyo University of Science

Hiroyuki Sakamaki is the professor for the Tokyo University of Science, School of Management. He is also the visiting research scientist for the Institute for Health Economics and Policy (IHEP) that is a non-profit corporation approved by the Ministry of Health, Labour and Welfare (MHLW). His specialties are health technology assessment including pharmacoeconomics and health expenditure analysis. He works research projects related to pharmaceutical policy, most of the researches are used as the basis for the discussion of healthcare system reforms. He graduated from Faculty of Pharmaceutical Science Hokkaido University (1978), Keio Graduate School of Business Administration (Business School, 1992). He received a Doctor Degree of Medical Science from Keio University. (2006)

Medicines for Europe

Florian Turk

Global Head Payor Marketing, Sales and Engagement - Sandoz and Vice-Chair of the Market Access Committee - Biosimilar Medicines Group, a Medicines for Europe Sector Group

Prof. Dr. Florian Turk is the Global Head Payor Marketing, Sales and Engagement at Sandoz Biopharma. He has more than 15 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz, Florian held several roles responsible for business-to-business commercialization, market access, pricing, public affairs and health economics in Novartis Pharmaceuticals and GlaxoSmithKline. Florian also holds responsibilities as Honorary Professor at the Department for Management, University of Paderborn. Florian holds a Master of Science in Economics and a Doctorate in Business Administration from the University of Trier in Germany.

Medicines for Europe

JOINT 23rd MEDICINES FOR EUROPE AND
20th IGBA ANNUAL CONFERENCE
LISBON, EPIC SANA LISBOA HOTEL
14-16 JUNE 2017


Medicines for Europe

Michele Uda

Director General - ASSOGENERICI and IBG, Associazione Nazionale Industrie Farmaci Generici e Biosimilari IBG – Italian Biosimilar Group Chairman of the EMAC (European Market Access Committee of Medicines for Europe)

Graduated in Political Science from the International University LUISS Guido Carli in Rome, with a specialization in International Economics, after an initial experience in one of the largest Italian trade unions, he has successfully completed a full time MBA in International Business and Economics at "Mib School of Management" of Trieste. He then continued his career in the retail consumer sector at Ferrero Italy as Assistant Brand Manager for the Italian multinational company's core business and, later, at Colgate Palmolive Italy as a market and industry sales analyst in the Household Care division. He stepped into the healthcare sector joining Johnson & Johnson Medical where he was responsible for direct management of sales and marketing for the breast care line in Italy’s central and southern regions. From March 2007 he joined Assogenerici, the Italian Generic and Biosimilar Medicines Association, as “Pharmaceutical Economics & Policy Affairs Manager”, assuming direct responsibility of the Centre for Economics and Policy Analysis of the association. From April 2012 he has been appointed Director General of Assogenerici, keeping also the position as interim head of the Centre for Economics and Policy Analysis and the responsibility for international relations. Since 2014 is also managing IBG – Italian Biosimilars Group, the new industry body representing the biosimilar medicines industry within Assogenerici.He is also member of the Executive Board of Medicines for Europe (European Generic & Biosimilars Medicines Industry Association - formerly known as EGA) as Chairman of the EMAC (European Market Access Committee of Medicines for Europe).


Medicines for Europe

Prof. Helder Mota-Filipe

Associate Professor of Faculty of Pharmacy - University of Lisbon and Former Member of the Executive Board – National Authority of Medicines and Health Products (Infarmed I.P.), PT

Prof. Helder Mota-Filipe is a former Member of the Executive Board of Infarmed, I.P., National Authority of Medicines and Health Products, since 2005. He was in charge of the Inspection, Licensing and OMCL sectors (2005-2010). He is currently responsible for the human medicines, medical devices sectors and OMCL. He is currently the coordinator of Infarmed’s taskforce on falsified medicines. He is Associate Professor of Pharmacology and Therapeutics and responsible for the Socio-Pharmacy Department at the Faculty of Pharmacy of the University of Lisbon. He is also Principal Investigator in Pharmacology and Translational Research Unit at the iMED (Institute for Medicines) from University of Lisbon. He holds a PhD (1996) in Pharmacology and a PharmD (1990) from the Faculty of Pharmacy of the University of Lisbon. He is extensively involved in the development of research programs, such as Immunopharmacology and pharmacological modulation in ischemia-reperfusion and shock. He is a member of several Scientific Societies. He has been Member of the National Research Ethics Committee (2004) and EMA expert in Human Medicines Safety (2003). He has been member of CHMP (EMA) between June 2011-July 2012.


Medicines for Europe

Jaime Espín

Professor – Andalusian School of Public Health

Jaime Espín has a PhD in Economics (University of Granada), a Bachelor Degree in Law (University of Granada) and a Master in Health Economics (Andalusian School of Public Health). He has been Visiting Graduate Fellow in the Department of Economics in the University of California (UCSB); Visiting Professor in Duke University (Fuqua Business School) and Columbia University (Mailman School of Public Health); and Visiting Researcher in The University of Chicago. He has also attended to specialized training activities in the University of Harvard and Oxford. He is Professor in the Andalusian School of Public Health, where teaches and coordinates projects related to health economics, economic evaluations and pharmaceutical policies. Prof. Espín is an expert in European pharmaceutical policies and has been external advisor for the European Commission during the High Level Pharmaceutical Forum (Working Group on Pricing). He has been member of the Experts Committee on Pharmaceutical Policies of the Pan American Health Organization (PAHO/WHO) and member of the Pricing Policy Group of the WHO/HAI Project on Medicines Prices and Availability. He is co-author of the European Commission publication “Differences and Commonalities in pricing and reimbursement systems in Europe” and co-editor of the Pan America Health Organization (WHO/PAHO) publications “The access to high cost medicines in the Americas” and “Guideline for implementing generic strategies in Latin America and the Caribbean as a mechanism to improve access to medicines”.


Medicines for Europe

Giovanni Tafuri

Senior HTA Officer – Italian Medicines Agency (AIFA)

Giovanni Tafuri, PharmD, PhD, is a Senior HTA Officer at the Italian Medicines Agency. He is involved in HTA activities at the national level - providing technical support to the AIFA’s Committees for the definition of pricing and reimbursement schemes - and at the international level, representing AIFA at different networks on HTA. Before joining the Agency in 2006, he worked at the World Health Organization in Geneva (2002-2003), at the Mario Negri Institute for Pharmacological Research in Milan (2005-2006) and recently as a National Expert on Secondment at the Office of Scientific Advice of the European Medicines Agency in London (2015-2017) on HTA/EMA Parallel Scientific Advice. Giovanni Tafuri holds a Master of “International Health Care Management, Economics and Policy” from Bocconi University and a PhD in Pharmaceutical Policy and Regulation from Utrecht University, The Netherlands.


Medicines for Europe

Gergely Németh

Project Manager - National Health Insurance Fund of Hungary (OEP)

Gergely Németh graduated as a pharmacist in 2014 in Budapest. He has been working at the department in charge of reimbursement of pharmaceuticals of the Hungarian authority for health insurance. He has been involved in the planning and implementation of the Hungarian generic pricing policy since 2007 and participated in the development of sofwares supporting pricing and reimbursement of pharmaceuticals. He has been the project manager of the EURIPID project since its establishment in 2010. The EURIPID project is a non-profit initiative of the national competent authorities of Europe for the mutual sharing of pharmaceutical price information.


Medicines for Europe

Victor Lino Mendonça

Head of Policy and Market Access Europe – Mylan

Victor Lino Mendonça is the European Head of Policy & Market Access at Mylan and Board member of Medicines for Europe. Formerly he was the Head of Pharmaceutical Policy and Health Economics at the EGA – European Generic medicines Association. Before EGA he was also Advisor to the Executive Board of Infarmed - The Portuguese National Authority of Medicines and Health Products and Advisor to the Portuguese Health Secretary of State. Victor also worked as Product Manager at Boehringer Ingelheim Portugal and in the fast moving consumer goods area.


Medicines for Europe

Michael Fadus

Vice President of Compliance – Teva

Originally from the US, Michael has been living and working in Switzerland since 2001, and also became a Swiss citizen in 2011. Michael is a qualified attorney (California) and compliance professional with over 20 years of achievement working at law firms and companies in the US, Germany, and Switzerland, supporting major markets in Europe, the Middle East, and Africa. He has extensive compliance experience in the pharmaceutical, financial services, and automotive industries, whether in Fortune Global 500, mid-sized, or start-up companies. In addition to compliance and law, Michael has held roles in global HR and communications. He has a bachelor's degree from Boston University, a master's and law degrees from the University of Texas, and an MBA degree from Thunderbird. He is a native speaker of English and fluent in German. Michael currently chairs the working group on the Code of Conduct at Medicines for Europe. He is currently VP of Compliance at Teva Pharmaceuticals, handling global teams in specialty medicines and patient solutions, as well as managing a team of 28 compliance professionals in Europe.


Medicines for Europe

Ema Paulino

Professional Secretary - FIP Executive Committee and President Lisbon and South Branch - Portuguese Pharmaceutical Society

Ema Paulino is a practising community pharmacist at her own pharmacy in Portugal. She is currently accountable for the development and implementation of pharmaceutical services in a virtual chain of 300 pharmacies. She is President of the Lisbon and South Branch of the Portuguese Pharmaceutical Society and a member of its National Board, and represents this organisation at various international groups and organisations such as the Pharmaceutical Group of the European Union (PGEU) and the International Pharmaceutical Federation (FIP). Previously, she was a member of the Board of the National Association of Pharmacies. Currently Professional Secretary of FIP, Ema has previously been Chairperson and Project Coordinator of the Young Pharmacists' Group, a member of the FIP Programme Committee, and Secretary of the Community Pharmacy Section. Ema is a member of the Pharmaceutical Care Network Europe (PCNE). She was primary researcher in an international collaboration on identification of drug related problems in discharged patients, under the umbrella of the Stevenshof Institute for Pharmacy Practice Research (SIR) and European Society of Clinical Pharmacy (ESCP), The Netherlands, having won the Health Base Foundation Poster Award at the 30th ESCP Conference in Antwerp, Belgium, in 2001, for the poster and oral communication “Drug related problems among patients discharged from hospital”. Ema also conducted research on facilitators of practice change in community pharmacy. Ema’s leadership positions include Secretary General and Permanent Officer in The Netherlands for the European Pharmaceutical Students’ Association (EPSA) 2000-2001, President of the Portuguese Pharmacy Students’ Association (APEF) 1999-2000, Chairperson of Health Information, Promotion and Education Working Group of the local Students’ Association 1998-2000, Member of the National Department of Health Information, Promotion and Education of APEF 1998-1999, Member of the Representative Assembly of the Faculty of Pharmacy of Lisbon 1997-2000, and Vice –President of the Highschool Students’ Association 1992-1994. She contributes with a monthly column on international pharmacy-related issues in the Portuguese Pharmacy Magazine “Farmácia Distribuição”.


Medicines for Europe

Robert Andrew Johnstone, FRSA

Patient Advocate

Chair: Access Matters, Midstream, Board Member: European Forum for Good Clinical Practice (EFGCP), Health Quality Improvement Partnership (HQIP), International Foundation for Integrated Care (IFIC). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation.


Medicines for Europe

Christophe Lesguer

CCO, Chief Compliance Officer Europe – Mylan GmbH

Christophe is French Citizen, even he is leaving in Switzerland for the last 3 years. He is commercial and trade lawyer by education and a compliance professional with almost 15 years of experience in compliance for US registered pharma companies, both listed on the Fortune 500. He was regularly moving from legal duties, to compliance duties with a lot opportunities and is embracing the whole set of rules required in both modern and global companies. For the last three years he participated actively in the EGA Ethics group and became Chair of the Transparency group for Medicines for Europe and contributed to the effort on Transparency. He’s currently leading Mylan Europe Compliance team, over 30 countries+ for the last 5 years, with various professional background.


Medicines for Europe

Heikki Pälve

CEO – Finnish Medical Association

Heikki Pälve is the CEO of the Finnish Medical Association. He graduated 1980 and specialised to anaesthesia and intensive care 1987. He serve in the Turku University Hospital as an associate professor in anaesthesia and intensive care 1988 – 2005. He worked as an emergency helicopter physician for five years. He was the president of the FMA 2001 – 2003 and started as the CEO 2005. He has been the vice-president of the Finnish Academics Organisation 2005 – 07 and 2011 – 13. He served as the Vice-President of the European Physicians’ (CPME) 2012 – 2015 and has been a board member since 2005. Dr. Palve has been an active delegate of the World Medical Association (WMA) since 2001. He has been the Chair of the Medical Ethics Committee since 2013 and will finish his term this spring. He has participated to the workgroup for the renewal of the latest version of the Helsinki Declaration (DoH). He has been working on the ethical documents concerning the relationship between the medical profession and the pharma industry as a member of the FMA in Finland, CPME in the European level and WMA in the global arena. Heikki has been also politically active and has been member of the city council in Turku and member of the board of the University of Turku.


Medicines for Europe

John Gisborne

Managing Director and Senior Partner – FleishmanHillard Fishburn

John Gisborne heads the Healthcare Practice at FleishmanHillard Fishburn in London. He also co-leads the company’s European Healthcare Practice.
John is a biochemist by training but has spent twenty years at the forefront of healthcare communications, helping clients in the public and private sectors achieve a range of commercial, risk mitigation and health outcomes.
With a keen interest in the transformation of communications, John has led some of the most innovative digital and social campaigns of their kind. He is currently engaged in a range of content-led programs to support new articulations of value in pharma. John’s teams have also conceived and activated the World Health Organisation’s initiative to prevent microbial resistance and post-surgical infection, ‘Missing Type’ for NHS Blood and Transplant and Efpia’s Big Data For Better Outcomes project.
John was appointed Board Director and Trustee of the International FH Foundation in 2013.


Medicines for Europe

Aidan Fry

Editor – Generics Bulletin

Aidan Fry has been the editor of Generics bulletin, the business newsletter for the generic and biosimilar medicines industry, since August 2008. He had previously been the deputy editor of Generics bulletin since the newsletter’s inception in 2003, having also spent five years working on its sister publication, OTC bulletin. A native English speaker, Aidan speaks German fluently. He resides with his wife and daughter in Birmingham, UK.


Medicines for Europe

Paul Tunnah

CEO and Founder – Pharmaphorum

Dr Paul Tunnah founded pharmaphorum in 2009, which has rapidly evolved and developed its services to drive better communication, connection and collaboration between the pharmaceutical industry and other healthcare stakeholders. He is a recognised author, speaker and moderator with a passion for helping organisations tell authentic stories that resonate, co-create solutions and unlock the power of digital and social media in connecting with customers and understanding markets. Prior to this, Dr Tunnah attained a BA in Biochemistry and DPhil in Biological Sciences, where he conducted research into novel anticancer agents, from Oxford University, before working in commercial consulting for Datamonitor, IMS Health and SmartAnalyst.


Medicines for Europe

Laetitia Tonel

Head of Communications – Mylan Europe

Laetitia Tonel is Head of Communications for Mylan Europe. She has held this position since 2012, having served for more than 10 years as a PR Director for the Fast-Moving Consumer Goods industry (Kellogg’s, Danone, Pernod Ricard). Laetitia is in charge of raising Mylan awareness across Europe as well as promoting key brands, generic medicines and biosimilars using both media and social media. She has developed the digital footprint of Mylan across Europe. Laetitia is the chair of Medicines for Europe Communication Group. Laetitia holds a Master’s degree of Law (France, Bordeaux) together with a Master’s degree in Communications - CELSA (France, Paris). She is a member of the European Association of Communication Directors in Brussels (EACD).


Medicines for Europe

Chris Lewis

Senior Manager External Communications – Sandoz Global Communications

Chris is a corporate communications professional with broad international experience, particularly in the pharmaceutical and energy sectors. He has been with Sandoz / Novartis for over 10 years, in roles ranging from Biopharma communications lead to US communications lead, as well as media relations and crisis management. He is currently responsible for financial and strategic communications within the Sandoz Global Communications team. Chris began his career as a journalist in the UK and Switzerland and subsequently managed a global PR mandate for clients in the energy industry, before joining Novartis. He holds an MA from Corpus Christi, Cambridge, and an MBA from Henley Management College. He is married with one daughter and his hobbies include travel, photography, scuba diving and mountain hiking.


Medicines for Europe

James Duggan

Principal Medical Writer – 90TEN/IGBA Communications Project

James has worked within medical communications for over six and a half years. During this time he has worked across several therapy areas, which include a number of biological treatments. In addition, James plays a hybrid role bringing science and digital learning to life. His focus is on learning theory and bringing the science to life, utilising storytelling to enhance knowledge retention. James also uses data visualisation to help improve comprehension of complex scientific data.
Prior to working in medical communications, James completed a PhD in Cell Biophysics at Nottingham University where he examined the interaction of molecules with cell membrane, and a Postdoctoral placement at the Institute of Ophthalmology, UCL, where he worked on glaucoma and ocular drug delivery. James is part of the team that has been involved in developing the IGBA’s latest educational materials.


Medicines for Europe

Evan O'Connell

Communications and Public Affairs Specialist – Aspect Consulting

Evan is a communications and public affairs specialist. He leads Aspect Consulting's public affairs and media activities in France, while also working on EU, UK and international PR and lobbying projects and campaigns for Aspect. He has worked for corporates and trade associations across a wide range of sectors including: food and drink, chemicals and life sciences, extraction and energy, sport, and telecommunications; as well as non¬profits and governments including the government of Georgia and Open Society Foundations.
Prior to joining Aspect, Evan was responsible for communications and public affairs for a major climate change research project in Paris, was a research assistant to a U.S. Congressman on Capitol Hill, and worked in publishing and business intelligence. A New Yorker by birth and a Londoner and Dubliner by upbringing, Evan has lived, worked and studied on three continents. A graduate of Sciences Po Paris, he holds a degree in Eastern European Studies and a master’s in Finance. In addition to his native English, he speaks near-native French, as well as Dutch, German and Czech.


Medicines for Europe

Sergio Napolitano

Legal and External Relations Director – Medicines for Europe

Sergio Napolitano is Legal and External Relations Director at Medicines for Europe. Before joining Medicines for Europe, Sergio Napolitano worked in the Directorate General for External Policies of the European Parliament where he was part of the Secretariat of the Committee on International Trade (INTA). In 2012, he authored a Report of the European Parliament on “The Role of the Congress in Shaping the US Trade Policy”. He previously worked in the Trade Policy Department of the Permanent Representation of Italy to the EU on multilateral, plurilateral and bilateral trade negotiations, EU investment policy and IPR. Sergio Napolitano is qualified for mediator certification in most American states. He holds a degree in Law from the University of Naples Suor Orsola Benincasa, an Erasmus Diploma at the Université Paris-Sorbonne, and a LL.M. on EU and European Public Law from the University College of London (UCL).


Medicines for Europe

Alan Sheppard

Principal, Global Generics and Biosimilars, Thought Leadership - QuintilesIMS

Alan has over 45 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations. In his role at QuintilesIMS he is responsible for developing services and insights for the industry and its associations on generic medicines and biosimilars through a combination of consulting, information and market analyses. Previous positions include Executive VP, Europe Generics, Dr Reddy’s; VP Global Corporate Strategy, PLIVA; European Marketing Director, Medeva; General Manager, Rhône-Poulenc Rorer UK; General Manager, Mérieux UK; and management roles with Servier and SKF. Alan is also an expert witness on patent litigation issues and their commercial impact, working with leading international law firms. Other roles have included Chairman, Technical Advisory Group, Access to Medicines Foundation; guest BRAPP lecturer, University of Wales working in the medicines faculty specialising in pharmaceutical marketing and clinical trials; a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board; Fellow, Chartered Institute of Management; Fellow, International Doctors’ Association and Member, Chartered Institute of Marketing.


Medicines for Europe

Alejandro Ollé

Partner and Co-founder - Galenicum

Alejandro Ollé, partner and co-founder of Galenicum, is the company’s responsible for B2C business, and has established operations in Latin America and South East Asian markets.
Prior to the founding of Galenicum, Alejandro worked as a consultant with Cluster Consulting where he was involved in international projects in Brazil, France, India and the MENA region.
Alejandro has a degree in Industrial Engineering and MSc. Applied Chemical Engineering by Institut Français du Pétrole.


Medicines for Europe

David Jauch

Senior Manager Global Regulatory Affairs, Government Relations – Fresenius Kabi

David M. Jauch is responsible for Government Relations within Global Regulatory Affairs of Fresenius Kabi. He is the Chairman of the Global Policy and Market Committee, Member of the Board of Medicines for Europe as well as a member of the Trade Committee of IGBA (International Generics and Biosimilar Association). Also, David is a member of the Regulatory Committee of the German Pharmaceutical Industry Association (BPI). David’s studied Business Administration at the University of Stuttgart in Germany, Tongji University in Shanghai, China and Seoul National University in Korea and holds an Executive Master in Business Management of Leeds University Business School in the UK.


Medicines for Europe

Oleh Syarkevych

Business Development Director – Farmak

At present Oleh Syarkevych works as a Business Development Director. Oleh is responsible for establishing business relations with foreign partners, expanding Farmak product portfolio through the In-licensing, introduction of the Company's products through Out-licensing partners to new markets.
Business Development Department headed by Oleh initiated and supported implementation of GMP EU, ISO 13485, FDA standards and drafting of documentation in CTD EU, ACTD formats.
Oleh Syarkevych represents Farmak at Medicines for Europe. He is also an outside expert of Ukrainian Association of Pharmaceutical Manufacturers.
Oleh worked in different areas of pharmaceutical business: pharmaceutical, scientific, industrial, and he also served as Chairman of the Board for Halychpharm.
Oleh Syarkevych is the author of about 50 scientific papers and over 20 patents. Oleh was awarded Certificates of Merit of the Ministry of Healthcare of Ukraine, and diplomas of the Kyiv City State Administration, medal and diploma of the Cabinet of Ministers.
In 1997 he earned his MBA degree from the Lviv Institute of Management.
Oleh served internship in the USA and Germany at pharmaceutical enterprises Parke-Davice Warner Lambert and Parke-Davis Gödecke.
Oleh graduated from the Lviv Medical Institute (at present known as Danylo Halytsky Lviv National Medical University). He earned his PhD degree in Pharmaceutics.


Medicines for Europe

Natalia Matting

Lawyer - DG Trade, European Commission

Natalia Matting is a trade negotiator in the European Commission, working mainly on regulatory barriers to trade impacting various industrial sectors, including in the pharmaceutical area. She has over 10 years of experience working in the European institutions on a number of policy areas. Before joining the institutions, she worked as an associate for Baker & McKenzie. Natalia studied law in Hungary and in the UK, and holds an LL.M. of European and Comparative Law from the University of Maastricht.


Medicines for Europe

Koen Nauwelaerts

Quality and Regulatory Manager – Medicines for Europe

Koen Nauwelaerts studied pharmacy at the University of Leuven, Belgium, holds a PhD in pharmaceutical sciences and obtained an MBA degree from Vlerick Business School. In 2015 he joined the EGA as manager Quality and Regulatory Affairs. Before joining Medicines for Europe, Koen was active in both QA and Regulatory Affairs roles at MSD (Merck Sharp and Dohme).


Medicines for Europe

Jacek Glinka

President – Medicines for Europe

Jacek Glinka is the President of Medicines for Europe and the President of the European Region for Mylan, one of the world’s leading global pharmaceutical companies which is dedicated to providing the world’s 7 billion people access to high quality medicine. Mylan is present in 35 countries in the European region and in approximately 165 countries and territories globally. Mr. Glinka has joined Mylan from the Polpharma Group, where he served as chief executive officer from 2003 to 2006 and from 2009 to 2013. During his tenure, he led the transformation of Polpharma from a local player into a leading pharmaceutical company in central and Eastern Europe, the Caucasus and central Asia. Prior to that, Mr. Glinka was a managing director at Spectra Services, where he oversaw a number of acquisitions and restructurings, including the acquisition and integration of Akrihin into Polpharma Group. He began his professional career as a strategic management consultant with firms including Deloitte & Touche and A.T. Kearney.


Medicines for Europe

Prof. Maria do Céu Machado

President – INFARMED

Maria do Céu Machado was appointed, through Resolution of the Council of Ministers published on June 2, president of the Board of Infarmed - National Authority of Medicine and Health Products.
The new Head was the Director of the Department of Pediatrics of the Hospital of Santa Maria and Professor of Medicine at the Faculty of Medicine of the University of Lisbon. Was also Vice-President of the National Health Council and Member of the National Ethics Council for Life Sciences. Between 2006 and 2011 she was the High Commissioner for Health.
She was honored as Grand Officer of the Order of Merit in 2010 and received the Gold Medal of the Ministry of Health in 2012.


Medicines for Europe

Adrian van den Hoven

Director General – Medicines for Europe

Adrian van den Hoven joined Medicines for Europe as a Director General in September 2013. His priorities at Medicines for Europe are to stimulate competition in off-patent medicine markets, to foster market access for generic, biosimilar and value added medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic, biosimilar and value added medicines industries. Prior to joining Medicines for Europe, Adrian van den Hoven was Deputy-Director General of BUSINESSEUROPE where he was responsible for the International Relations department, covering trade negotiations and bilateral relations, and the Industry department, covering industrial, energy, environmental and research policy. He previously worked as an International Relations researcher and an adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor). He obtained his doctorate in Political Science from the University of Nice, France in 2000.


Medicines for Europe

Rabia Khan

Health Division – OECD

Rabia Khan is a health policy analyst at the OECD, working mainly in the pharmaceutical area. She has worked as an epidemiologist in government and academic institutions in New Zealand, Australia and the United Kingdom with over 15 years of experience in the health sector. She is a Fellow of the UK Faculty of Public Health. Her main interests are in improving health and reducing health inequalities though better use of technology, information and evidence.


Medicines for Europe

Christa Cepuch

Pharmacist Coordinator - MSF Access Campaign

Christa Cepuch is a pharmacist with a Master of Public Health. She has recently joined the Médecins sans Frontières (MSF) Access Campaign as Pharmacist Coordinator. The Campaign’s purpose is to push for access to, and the development of life-saving and life prolonging medicines, diagnostic tests and vaccines for patients in MSF programs and beyond.


Medicines for Europe

Alex Harris

CEO – International Health Partners

Alex is a political consultant turned humanitarian, now using his advisory experience to advocate for increased private sector engagement and collaboration in improving access to medicine in frontier markets and fragile states. Prior to joining IHP, he worked as a lobbyist to the pharmaceutical industry, foreign governments and a diverse range of companies who required expert knowledge of the UK and European political systems. During his ten years at IHP, Alex has also served as Head of Corporate Partnerships and Director of Operations. IHP’s mission is to help those without access to medicine in the developing world by coordinating the safe and responsible donation of medical products from the healthcare industry across Europe.


Medicines for Europe

Robert Andrew Johnstone, FRSA

Patient Advocate

Biography see above.


Medicines for Europe

Pierluigi Antonelli

Head of Western Europe – Sandoz

Pierluigi Antonelli, in Sandoz since August 2015, is Head of Western Europe for Sandoz International and Member of the Sandoz Executive Committee. Pierluigi started his career as entrepreneur in the automotive business before joining McKinsey, where he worked both in the US and Italy. He then spent the last sixteen years in the Pharmaceutical/Healthcare industry, starting his career at Bristol-Myers Squibb where he held several executive roles in different geographies (Italy, Portugal, US, France and Switzerland). After moving in 2011 to Merck & Co in Italy, he successfully acted as Senior Vice President in Italy and Europe/Canada Fertility Lead over a 1.2 billion USD business with more than 1.000 employees. Pierluigi joined Medicines for Europe in 2016 as Vice President and Treasurer. An Italian national, Pierluigi holds an MBA from Kellogg Graduate School of Management and a degree in Business and Economics from L.U.I.S.S. University.


Medicines for Europe

Jacek Glinka

President – Medicines for Europe

Biography see above.


Medicines for Europe

Jim Keon

President – Canadian Generic Pharmaceutical Association and President - Biosimilars Canada

Jim Keon is President of the Canadian Generic Pharmaceutical Association (CGPA), and President of Biosimilars Canada organizations representing Canada’s generic and biosimilar pharmaceutical sectors.
Jim graduated with an M.A. in Economics from Queen’s University, and has more than 20 years experience in the pharmaceutical sector.
Jim has served as President of the CGPA since 1998 and was named the founding President of Biosimilars Canada in January 2015. Prior to joining CGPA in 1994 he held senior positions in the federal government and was directly involved in international trade negotiations for NAFTA and the WTO, as well as Canada’s inter-provincial trade negotiations.
Jim is Past Chair of the International Generic and Biosimilar Medicines Association (IGBA), which is committed to promoting the interests of generic and biosimilar medicines around the world. He is currently Chair of the IGBA International Trade Committee.


Medicines for Europe

Alan Sheppard

Principal, Global Generics and Biosimilars, Thought Leadership - QuintilesIMS

Biography see above.


Medicines for Europe

Kyozo Inari

Executive Corporate Officer, External Affairs Department - Sawai Pharmaceutical Co.,Ltd. and Chair International Affairs Committee - JGA

Since 2008, he has served as head of external affairs department at Sawai Pharmaceutical Co.,Ltd and he is also the current chair of the international affairs committee of JGA.
Before joining the Sawai, he had been working for the Ministry of Health and Welfare since 1974, where he accumulated experience in the field of product review, GLP, GCP, drug pricing and control of narcotics. He also had work experience at the National Cancer Center Hospital and PMDA (Pharmaceutical and Medical Devices Agency).
He is a Pharmacist, graduated from the master course of Kyoto University (Faculty of Pharmacy) in 1974.


Medicines for Europe

John McCullough

VP Commercial Generics Europe & Global In-line Portfolio Management – Teva

I’ve worked in the industry since 1996 across both Innovator, Parallel Trade and more recently in Teva for the last 1O years in the Generic space, where I current hold the position of Vice President for Commercial Portfolio Europe and globally look after the optimisation strategies that allow Teva to offer a wide range of generic medicines in keeping with our top and bottom line objectives.
My experience working in and out of country across sales and marketing roles, business development and M&A, and portfolio has allowed me the privilege of experiencing market access challenges and creating solutions at all levels. Strategic choices on geography, size of entity, operational capabilities, commercial go to market strategies, effective price and reimbursement, and knowledge of market trends, are at the heart of what I do. If strategic choice is the heart, then Execution is the life blood and without it the heart is useless. So with that said I’m responsible to ensure delivery of strategies with our stakeholders, so not only enabling market access for generics, but for me the most important word “sustainability” for both our patients, customers and our corporate objectives.


Medicines for Europe

Tony Mauro

Chief Commercial Officer - Mylan

Anthony (Tony) Mauro is Mylan’s Chief Commercial Officer, overseeing commercial businesses around the world. Tony is responsible for leading and executing Mylan’s global commercial strategy for the company’s more than 7,500 marketed products in more than 165 countries and territories. Mauro has been with Mylan, a leading manufacturer of generic pharmaceuticals, for more than 20 years serving in several capacities. Most recently, he served as president of North America, successfully leading the company’s largest commercial business. Prior to that role, Mauro served as president of Mylan Pharmaceuticals Inc., the company's flagship generics division in the U.S.; chief operating officer of Mylan Pharmaceuticals ULC in Canada; vice president of North America Strategic Development; and vice president of North America Sales. In 2012 and 2013, Mauro served as chairman of the board of directors for the U.S. Generic Pharmaceutical Association (GPhA), which represents the world's leading generic drug manufacturers and suppliers. Prior to that he served two consecutive terms as vice chairman of the board for GPhA, now known as the Association for Accessible Medicines.


Medicines for Europe

Michele Uda

Director General - ASSOGENERICI and IBG, Associazione Nazionale Industrie Farmaci Generici e Biosimilari IBG – Italian Biosimilar Group Chairman of the EMAC (European Market Access Committee of Medicines for Europe)

Biography see above.


Medicines for Europe

Gian Mario Baccalini

President – Aschimfarma and Chair – European Fine Chemicals Group

President of Aschimfarma since 2011 and Chairman of the PAC (Pharmaceutical Activities Committee) / EFCG (European Fine Chemical Group Cefic) since 2009. He began his experience in the 70s as Production Manager and Plant Manager in Pierrel, a diversified Italian company in all areas of health. He gained experience in handling different plants with production of APIs for synthesis and fermentation, final dosage injectable and not, OTC, medical devices. In this company in the 80s reached the position of General Manager and Vice President, developing all the business activities with significant improvement in marketing, business development and sales though the worldwide market. During this years he had important experience in USA managing local facilities and commercial relationsship with big pharma. Later, after a brief experience in a new biotechnology french company, with a group of entrepreneurs, acquired Alfa Chemicals which later became PFC, with acquisitions in the United States and in Italy. In PFC he was Managing Director. The Group was sold to Honeywell USA in 2000.with a very high multiple of EBITDA, after five years of the important growth performing excellent result in revenues and profitability. In the early 2000s he began his experience in the Association, holding the position of President of Aschimfarma from 2003 to 2009 and being also a member of the Board of Federchimica. In 2006 he founded a research center for technology development which was sold in 2016. During this period of time he was very active collaborating with private equity group in merger and acquisition. He was Chairman of the Group Euticals in the period 2013-2014 during the period of integration needed after 2 important acquisitions.


Medicines for Europe

Dinesh Dua

Vice Chairman - Pharmaceuticals Export Promotion Council of India

Dr. Dinesh Dua, is currently the Chief Executive Officer & Whole Time Director of M/S Nectar Life sciences Ltd.-a US$ 310 Mio.(Rs. 2000 Crs.) Niche company in life sciences.
Immediately prior to NLL, he was Managing Director of Akorn India Pvt. Ltd.,a 100% subsidiary of US MNC,Akorn Inc., which was a sequel to a very successful 6 year stint at M/S Nectar Lifesciences Ltd. As CEO & Director on Board between 2007 & 2012.
Mr. Dua holds a Masters in Business Management (M.B.A.)-1979 batch from Harvard Business School promoted, Indian Institute of Management Ahmedabad.
He has over 38 years of professional experience across varied industries in leadership positions such as Healthcare, Pharmaceuticals & Biologicals, Petrochemicals and Consumer goods, having worked in multinational organizations such as Hoechst (Sanofi Aventis), Berger Paints, and large Indian Corporates like Reliance, Jubilant Organosys, Zydus Cadila Healthcare & as President of Wockhardt Ltd’s International & Biotechnology Strategic Business Unit (SBU).
He is currently North India Chairman for Higher Education for Confederation of Indian Industry (CII) & is also immediate Past Chairman of CII, Chandigarh Council, Vice Chairman, Pharmaceuticals Export Promotion Council (Pharmexcil)-A part of Ministry Of Commerce, Govt. of India, Member Executive Council, Bulk Drug Manufacturers Association (BDMA),Advisor for International Business for Federation of Pharmaceuticals Entrepreneurs (FOPE) & is also a visiting faculty to leading & reputed Management institutes in India.


Medicines for Europe

Satoshi Kawamura

Senior Vice President – Nipro Pharma Corporation

Satoshi Kawamura is the senior vice president of Nipro Pharma Corporation, which is the largest CDMO in Japan,and he is currently supervising the Business Development Division. He has more than 20 years’ experience in pharmaceutical manufacturing field, starting his career as a production engineer and set up 7 manufacturing lines for sterile injectables such as dual chamber bags (PLDB®), prefilled syringes and lyophilized vials. On occasion of establishing Odate plant in 2002, which is one of the mother plants of Nipro Pharma, he was assigned as the Plant Director and successfully led the starting-up of another 13 lines, including dual chamber prefilled syringes.
In 2012, he was assigned also as General Director of Nipro Pharma Vietnam Co.,Ltd, which is the first overseas subsidiary of Nipro Pharma and successfully started commercial operation on original schedule.


Medicines for Europe

Jody Cox

Vice President Federal and International Affairs, Canadian Generic Pharmaceutical Association and Vice President, Biosimilars Canada

Jody has been responsible for the CGPA’s intellectual property, legal affairs and trade files since 2007. She was active on behalf of the generic and biosimilar medicines industries in both the negotiations for a Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union and the Trans-Pacific Partnership (TPP) negotiations, and is currently focused on the Canadian implementation of CETA. She coordinates the CGPA’s legal activities, which has included several successful interventions in pharmaceutical patent matters at the Supreme Court of Canada. In addition to her work with CGPA, Jody is Vice President of Biosimilars Canada, the voice of Canada’s biosimilar medicines industry, where she has been responsible for scientific regulatory affairs, legal affairs and market access since its inception in January 2015. She is also an active member of the International Generic and Biosimilar Medicines Association (IGBA), and serves as Secretariat to the IGBA International Trade Committee and is a member of the IGBA Biosimilars Committee.


Medicines for Europe

Marc-Alexander Mahl

Executive Vice President Business Unit Generic Drugs – Fresenius Kabi and Chair Hospital Working Group – Medicines for Europe

Marc-Alexander Mahl is heading since 2011 the global Business Unit Generic Drugs & Standard Solutions at Fresenius Kabi. Since he joined Fresenius in 2001 Marc had multiple global and regional management positions in Medical Devices, Marketing and the Generics & Standard Solutions business of Fresenius Kabi with the responsibility to create a globally balanced, profitable and sustainably growing generic drugs business for Fresenius Kabi. Marc´s mission outside of Fresenius Kabi is to make the European generics business again more attractive for pharmaceutical companies and local investments in manufacturing. Being a physician by training Marc completed in 2001 his specialization in transfusion medicine / blood banking. In 2008 Marc received his eMBA degree from INSEAD (Fontainebleau / Singapore).


Medicines for Europe

Annie Pannelay

Principal – The Economist Intelligence Unit

Annie Pannelay leads the healthcare consulting practice of the EIU. Her role is global. The healthcare vertical includes the policy analysis services to the industry, as well as more specialised services, including value consulting. She helps her clients navigate the challenges presented by the current environment, including the increasing need for clinical and economic evidence required by healthcare policy-makers, insurers and payers. Prior to joining the Economist, Annie held roles with various stakeholders in the healthcare industry. Her experience include working as resident hospital pharmacist (Nice CHU, France), working for the pharmaceutical industry in market insights and business planning roles, as well as healthcare banking. Most recently before joining the Economist Intelligence Unit, Annie worked as strategy consultant, advising top pharmaceutical companies. She also currently is the vice-president of the UK Chapter for ESSEC Alumni, the international network of ESSEC Business School, organising professional events for the alumni community in the UK. She has worked in Europe, Hong Kong and New York. Annie holds a Doctor of Pharmacy Degree from Montpellier University, a BSc in biologic and medical sciences from Montpellier University and an MBA from ESSEC business school in Paris. She is fluent in English and French.


Medicines for Europe

Maggie Dolan

Regional Pharmacy Procurement Specialist – NHS Commercial Solutions Surrey

Maggie Dolan obtained her pharmacy degree from Heriot Watt University, Edinburgh in 1978 and her clinical pharmacy diploma from Strathclyde University, Glasgow in 1991. She has spent most of her career in the NHS in the hospital pharmacy sector but did work for a short time in the pharmaceutical industry with MCP Pharmaceuticals assisting in the Medicines Information and New Product Registration functions. She has been responsible for pharmacy services in both the adult and paediatric settings having been Chief Pharmacist of Edinburgh Sick Children’s NHS Trust and West Lothian NHS Trust .Over the last 15 years she has developed a keen interest in medicine logistics, procurement and contracting in the NHS both as Pharmacy Advisor to National Procurement National Services Scotland and currently as Regional Procurement Specialist South East Coast, England. She is a strong advocate of the delivery of Medicine Optimisation as part of routine practice and chairs the NHS Biosimilars group and the National Purchasing and Distribution Interest Group. She believes the appropriate adoption of biologics including biosimilars is essential for the NHS and patients.


Medicines for Europe

Aida Batista

Director of Professional Development – European Association of Hospital Pharmacists (EAHP)

Degree in Pharmaceutical Sciences, Faculty of Pharmacy, University of Lisbon (1987) Specialization in Hospital Pharmacy (1994) Postgraduate Course in Management and Leading of Health Services, Faculty of Economics, University of Porto (2006) PADIS - Advanced Management Program for Healthcare Organizations, AESE Busibness School (2016) Hospital Pharmacist since 1987 Senior Pharmacist, Centro Hospitalar de Vila Nova de Gaia (CHVNG/E) (2003-2013) Member of Drug and Therapeutic Committee, CHVNG/E, since 2004. Director of Pharmacy Department, CHVNG/E, since July 2013 Board Member of a Union of civil servants: STE – Sindicato dos Quadros Técnicos do Estado (1990-1992). Board Member of the Portuguese Association of Hospital Pharmacists - APFH (2002-2005) President of APFH, (2008- January 2015) Delegate to the General Assembly of the European Association of Hospital Pharmacists - EAHP (2009-2010; 2015) EAHP Board Member, Director of Professional Development


Medicines for Europe

Marcel T.M. van Raaij, PhD

Director Ministry of Health – The Netherlands

Marcel van Raaij studied Medical Biology at the State University of Leiden (The Netherlands) and received his PhD in Physiology at the same university. After his PhD he moved to the field of toxicological risk assessment stationed at the National Institute of Public Health and Environment (RIVM). He was active in various international working groups and commissions (EU,WHO, OECD, US EPA) dealing with regulatory frameworks on e.g. pesticides, biocides and accidental exposures to (industrial) chemicals. After leading the Center for Integrated Risk Assessment for a number of years at RIVM, he became acting director for Nutrition, Medicines and Consumer Safety. From 2011 to 2014 he was Director of Environment and Safety at RIVM dealing with environmental policy and physical safety including preparedness and response activities. In October 2014 Marcel van Raaij was appointed as Director of Pharmaceutical Affairs and Medical Technology at the Ministry of Health in the Netherlands. The Directorate is responsible for the policy making on pharmaceuticals (from innovation, market access, safe use to pricing and reimbursement), medical devices and technology and tissues and cells including organ donation policy. The Netherlands presented a new Pharma policy in January 2016.


Medicines for Europe

Dominik Tomek

Board Member – European Patients Forum (EPF)

Dr. Dominik Tomek, PharmD., PhD., MPH, 1956, has experience in public and hospital pharmacies, government administration and regulatory agency incl. oncology hospital, Ministry of Health and Health Insurance. He was elected as director in the ISPOR Board of Directors for the term 2014 – 2016 and serves as a chair of education committee of ISPOR CEE Network. Dr. Tomek served for many years in the Drug Committee of State Institute for Drug Control, Pricing Committee of Ministry of Finance and Reimbursement Committee of Ministry of Health. He is teaching at the Faculty of Medicine, Slovak medical university, Bratislava, Slovakia. He is vice president and scientific advisor to the Association for the Protection of Patient Rights in Slovak republic for second term and Board Member of the European Patients Forum in Brussels for second term.


Medicines for Europe

Yi-Yun (April) Wang

Legal Manager - Yung Shin Pharm. Ind. Co., Ltd. and Chair, International Affairs Committee – Taiwan Generic Pharmaceutical Association (TGPA)

Yi-Yun (April) Wang is the current chair of the International Affairs Committee of TGPA. Since 2008, she has served as the manager of the legal department at Yung Shin Pharm. Ind. Co., Ltd. where she oversees the company’s legal matters, including litigation, Paragraph IV matters, contracts, legal analysis and mergers & acquisitions. Ms. Wang has received extensive training in the areas of IP and technology management. She was selected by the Taiwan Department of Industrial Technology to participate in intellectual property and technology management training programs sponsored by the George Washington University Law School, the Asia-Pacific Legal Institute and the University of California, and also in IP training focused on European IP law in cooperation with the Max Planck Institute and the European Patent Office. She has an LL.M. at the Soochow University School of Law, and also holds both a B.S. & M.S. in Nutrition and Health Science from Taipei Medical University’s College of Public Health and Nutrition.


Medicines for Europe

David R. Gaugh, R.Ph.

Senior Vice President for Sciences and Regulatory Affairs - Association for Accessible Medicines (AAM)

David Gaugh has over 25 years of leadership experience in the Healthcare and Pharmaceutical business. He has been employed by AAM (formerly GPhA) since February 2012 as the Senior Vice President for Sciences and Regulatory Affairs, where he is responsible for the professional liaison functions between member companies, agencies of the US Government and Legislative bodies for all responsible areas. Prior to joining AAM, David was Vice President and General Manager of Bedford Laboratories, a Division of Ben Venue Laboratories and a wholly owned subsidiary of Boehringer Ingelheim.Prior to Bedford Laboratories, David was Senior Director, Pharmacy Contracting and Marketing at VHA/ Novation (now Vizient). And prior to VHA/Novation, David was System Director of Pharmacy for St. Luke’s Health-System, a tertiary-care hospital in Kansas City, MO. David is a registered Pharmacist and has been engaged in several board-level pharmacy-related activities such as; the American Society of Health-system Pharmacists Education and Research Foundation Board of Directors, USP Council of Convention, and American Foundation for Pharmaceutical Education Board of Directors.


Medicines for Europe

Sabine Kopp, Dr

Group Lead, Medicines Quality Assurance – WHO

Sabine Kopp is Group Lead of WHO’s Medicines Quality Assurance and has worked for the World Health Organization (WHO) since 1986. She was, inter alia, Secretary for the International Nonproprietary Names (INN) Programme, Acting Team Coordinator for Quality Assurance and Safety of Medicines, Programme Manager for the Quality Assurance and the Anticounterfeiting programmes, Acting Secretary of the International Medical Products Anti-Counter-feiting Taskforce (IMPACT) and was also actively involved in the WHO Member State mechanism on Substandard/ spurious/ falsely-labelled/falsified/counterfeit medical products medical products. Sabine Kopp is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and is responsible for the coordination of WHO's activities related to the development and maintenance of international guidelines, GXPs, standards and norms related to Medicines Quality Assurance, i.e. the normative work related to Medicines Quality Assurance within WHO, spanning from development and manufacturing to the distribution and supply of the medicines.


Medicines for Europe

Brendan Cuddy

Head of Manufacturing and Quality Compliance, Committees & Inspections Department - European Medicines Agency (EMA)

Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002. Brendan is currently Head of Manufacturing and Quality Compliance Service and he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). The Manufacturing and Quality Compliance Service is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party. The Service plays a key role in collaborating and communicating with international partners on setting and recognising GMP standards, making better use of inspectional resources and exchanging information on availability of already authorised medicines. Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.


Medicines for Europe

Nuala Calnan

Senior Associate Compliance Practice - Lachman Consultant Services, Inc.

Nuala Calnan, Ph.D., is a Senior Associate in the Compliance Practice at Lachman Consultants delivering consultancy services to the pharmaceutical, biopharmaceutical, medical devices and diagnostics industries. With 25 years’ industry experience, Dr. Calnan has authored international industry standards and guidance documents on validation, qualification and risk-based verification approaches, including the ASTM E2500:07 verification standard. She continues to publish in the field of excellence for the biopharmaceutical industry.
In the course of her career, she has led multi-disciplinary front-line teams supporting day-to-day manufacturing operations and new facility start-ups. She specializes in transforming compliance-led quality management systems by enabling organizations to focus on delivering quality excellence through the integration of cultural excellence, knowledge excellence and operational excellence strategies.
Dr. Calnan is also an Adjunct Research Fellow in Regulatory Science at the Dublin Institute of Technology. Her own research includes examining quality metrics for the US Food and Drug Administration (FDA) and quality defects and product recalls for the Irish Health Products Regulatory Authority (HPRA).
Recent Publications
 Knowledge Excellence in the Biopharmaceutical Industry, Taylor and Francis – CRC Press (June, 2017)
 Cultural Excellence Report, ISPE (April, 2017)
Professional Affiliations
 ISPE: Co- Chair of the Quality Culture Team;
 Core Team Member of ISPE Quality Metrics Team;
 Co-chair of PQLI Task Team for Knowledge Management


Medicines for Europe

Mechthild Sander

Qualified Person - Alfred E. Tiefenbacher (AET)

Working at AET since 1999, starting with regulatory affairs establishing a Quality department and system at AET and working as Qualified Person at AET. Since 2016 working part-time on specific projects in Quality and GMP questions and as Qualified Person. Before joining AET, Mechthild Sander worked since 1985 in Quality Control in several pharmaceutical companies, such as Desitin Arzneimittel GmbH, D-Hamburg, Rottendorf GmbH, D-Ennigerloh and Bela Pharm, D-Vechta.


Medicines for Europe

Christoph Stoller

SVP Chief Operating Officer GGM Europe - Teva Pharmaceuticals Inc. and Vice President - Medicines for Europe

Christoph Stoller is Teva’s Chief Operating Officer Europe. Most recently he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe, in that role he was also responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph serves as Vice President of Medicines for Europe and chairs the sector group on Value Added Medicines. He has been working for Teva Europe since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re. Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland.


Medicines for Europe

Mondher Toumi

Professor – University of Aix-Marseille

Professor Mondher Toumi is M.D. by training, M.Sc. in Biostatistics, and in Biological Sciences (option pharmacology) and Ph.D. in Economic Sciences. Mondher Toumi is Professor of Public Health at Aix-Marseille University.
After working for 12 years as Research Manager in the department of pharmacology at the University of Marseille, he joined the Public Health Department in 1993. In 1995 he entered the pharmaceutical industry and worked there for 13 years.
Mondher Toumi was appointed Global Vice President at Lundbeck A/S in charge of health economics, outcome research, pricing, market access, epidemiology, risk management, governmental affairs and competitive intelligence.
In 2008, he founded Creativ-Ceutical, an international consulting firm dedicated to support health industries and authorities in strategic decision-making.
In February 2009 he was appointed Professor at Lyon I University in the Department of Decision Sciences and Health Policies. The same year, he was appointed Director of the Chair of Public Health and Market Access. He launched the first European University Diploma of Market Access (EMAUD) an international course already followed by almost 400 students. Additionally, he recently created the Market Access Society to promote research and scientific activities around market access, public health and health economic assessment. Since 2009, he also chairs the Annual Market Access Day, a purely academic event. He is Editor in Chief of the Journal of Market Access and Health Policy (JMAHP) a PubMed indexed journal.
Since September 2014, he joined the research unit EA3279 of the public health department, at Aix-Marseille University (France) as full Professor. Mondher Toumi is also visiting Professor at Beijing University (Third Hospital).
He is a recognized expert in health economics and an authority on market access and risk management. He has more than 200 scientific publications and oral communications, and has contributed to several books. He recently published a book Introduction to Market Access for Pharmaceuticals (CRC Press).


Medicines for Europe

Robert Andrew Johnstone, FRSA

Patient Advocate

Biography see above.


Medicines for Europe

Sampreet Ramachandra

Director Global Portfolio and Strategic Marketing – Fresenius Kabi

Sampreet Ramachandra is with Fresenius Kabi since 2009 and currently serves as the Director of Strategy after handling different positions in India, UK & Germany in the past. His passion is for an ever-better healthcare across the world & keen interest in the role of pharmaceuticals in Fresenius Kabi's shared mission of caring for life. He holds degrees in Engineering, Health Economics & an MBA and is an alumnus of the London School of Economics & Indian Institute of Technology.


Medicines for Europe

Antonio Vaz Carneiro

Head - Centre for Evidence-Based Medicine (CEMBE), Faculty of Medicine of the University of Lisbon

With 40 years of professional experience in Portugal and the US, António Vaz Carneiro is a Medical Doctor holding specialist degrees in Internal Medicine, Nephrology and Clinical Pharmacology. He is also a Professor at the Faculty of Medicine, University of Lisbon (FMUL) where he directs the Center for Evidence Based Medicine, having several other educational and scientific responsibilities in the FMUL. He is a Clinical Researcher with special interest in the areas of secondary research (systematic reviews and meta-analyses), methodologies of translation of knowledge into practice and systems to support clinical, administration / management, health policy decision-making and to increase health literacy of citizens. Prof. Vaz Carneiro is the Head of Cochrane Portugal.


Medicines for Europe

Hanan Sboul

Secretary General – Jordanian Association of Pharmaceutical Manufacturers

After more than 10 years of work at Jordan Food & Drug Administration JFDA, Hanan has joined the Jordanian Association of Pharmaceutical Manufacturers JAPM back in 2003 as a Secretary General. She utilized her regulatory expertise in assessment of generic dossiers & quality control, her knowledge on IPR and her skills in lobbying & advocacy to represent the Jordanian generic industry in Jordan and internationally. Hanan is a member of USP Council Governance Committee for 2015 – 2020 Cycle and was a member of the USP Council of Convention for 2010- 2015 Cycle. She is also a member of the Steering Committee for Jordan Pharmaceutical Center of Excellence, a Board member of the Fund for Employment, Technical, Vocational Education & Training, a member of the Steering Committee of Medicine Transparency Alliance. Hanan is also a member of Scientific Research Support Fund & an ex member of the Hashemite University Board of Trustees. Hanan received her MBA from Jordan University and her B.A in pharmacy from Yarmouk University in Jordan in 1986.


Medicines for Europe

Carol Lynch

Head Global Biosimilars – Sandoz

Carol Lynch is the Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. She leads a 3000+ person organization focused on the development, manufacturing and commercialization of biosimilars and oncology injectables. She is also responsible for Sandoz’s biopharmaceutical contract manufacturing business. Lynch has more than 25 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz in 2014, Lynch held several Commercial and Development leadership positions in Novartis Pharmaceuticals both globally and in country organizations, including the United States. She is a member of the Sandoz Executive Committee and Chair of the Biosimilar Medicines Group.


Medicines for Europe

Catarina Nobre

President – EPSA

Catarina is 24 years old, finishing her Master’s degree at the Faculty of Pharmacy of the University of Lisbon. Since the beginning of her academic life, she had a high interest in the associative segment and started to be an active member of the local students’ association, participating in the most diverse organising committees for students’ events. With the increasing intercultural curiosity and potential discovered in the European Pharmaceutical Students’ Association (EPSA), Catarina partook in the Reception Committee of the EPSA Summer University 2015 is Lisbon, as Partnership Officer and Treasurer. Soon after, she decided to successfully run for EPSA Treasurer. After experiencing two consecutive mandates as EPSA Treasurer and as an Executive member (2014-2015 and 2015-2016), in April 2016, she applied to be EPSA President 2016-2017. Currently, she holds the position of EPSA President, managing a Team of 28 individuals and representing over 160.000 pharmacy students across Europe.


Medicines for Europe

Elisabeth Stampa

CEO – Medichem

Born in Barcelona, Spain, in 1967.
Elisabeth graduated in Pharmacy at the Universidad de Barcelona, Spain in 1990 and after one year as Scientific Consultant she continued her studies to get a Master in Business Administration at ESADE Business School, Barcelona, Spain with a student exchange program in Cranfield Business School, UK.
She started her career in Laboratorios Esteve SA. Three years after she joined the family owned business (Medichem SA and Combino Pharm SL) devoted to Active Pharmaceutical Ingredients (APIs) and Finished Dosage Products (FDFs) and served as Managing Director at Combino Pharm SA. In year 2000 she moved to the Corporate structure of the business as General Manger. After the divestment of part of the business in 2015 she became Executive Chairwoman and since July 2016 acts as CEO for Medichem SA.
Elisabeth participated in the negotiations representing the European Active Ingredients industry in the GDUFA II negotiating round.


Medicines for Europe

Suzette Kox

Senior Director International - Biosimilar Medicines Group, a Sector Group of Medicines for Europe and Chair Biosimilars Committee - International Generic and Biosimilar Medicines Association (IGBA)

Suzette Kox was nominated Senior Director International in October 2015, following 14 years in the position of EGA’s Senior Director Scientific Affairs and Coordinator of the Biosimilar Medicines Group (formerly called European Biosimilars Group), a sector group of Medicines for Europe (formerly EGA). She is also Chairperson of the Biosimilars Committee of the International Generic and Biosimilar Medicines Association (IGBA) where she is leading currently a global biosimilars communication project.
Suzette has been involved with biosimilar medicines in Europe since 2001 and has been until 2015, the Programme Director of the association’s annual Biosimilars Conference, which has become over the years the main annual gathering of the world’s key biosimilars regulators and experts. In her positions, she has given numerous presentations on generic and biosimilar medicines at conferences around the world.
Previously she worked for 10 years in regulatory affairs and management for the German pharmaceutical company ratiopharm (now Teva) and was Chair of the EGA Regulatory & Scientific Affairs Committee and member of the EGA Board and Executive Committee. She was also a visiting faculty member of the School for International Training: Department Development Studies and Public Health in Geneva. Before joining the generic and biosimilar medicines industries in 1991, she followed a hospital and retail pharmacy career. Along with a degree in pharmacy (Paris), Suzette holds a postgraduate diploma in anatomy-pathology (Cochin Port Royal, Paris) and is multilingual.


Medicines for Europe

Belinda Wood

CEO – Generic and Biosimilar Medicines Association (GBMA), Australia and Vice-Chair of the IGBA Biosimilars Committee

Belinda Wood is the CEO of the Generic and Biosimilar Medicines Association (GBMA), the Australian association representing companies that manufacture, supply and export generic and biosimilar medicines. Belinda has over 22 years’ experience in the pharmaceutical industry and was appointed CEO in December 2014 having been the organisation’s Policy Director from 2012. Belinda was pivotal in negotiations leading to the signing of a Strategic Agreement with the Australian Government in May 2015 that recognises the important role of generic medicines and biosimilars in PBS affordability. Belinda holds a BMedSc in Pharmacology and is a graduate of the Australian Institute of Company Directors. She proudly contributes to the work of the IGBA Trade Committee, and is the deputy-chair of the IGBA Biosimilars Committee.


Medicines for Europe

Paulo Lilaia

President – Apogen

Paulo Lilaia is currently the president of the Portuguese Generic and Biosimilar Medicines Association (APOGEN) since 2008. APOGEN, founded in 2003, represents generic and biosimilar medicines companies and is responsible for communicating to stakeholders on behalf of members.
He holds a Masters in Business Administration and an Executive MBA, both from ISCTE Business School, having previously made his education at ISPA, Institute of Applied Psychology, and ESSA, School of Health Alcoitão. His career also includes, among others, training in management and marketing at INSEAD in France and Ashridge University in England.
Since July 2010, he is the Chief Executive Officer of Generis Farmacêutica, S.A. and previously was Director General of Ratiopharm Portugal between 2004 and 2010.


Medicines for Europe

José Inácio Faria

MEP – EPP Portugal

Member of the European Parliament since 2014 and member of several Committees among which the Committee on the Environment, Public Health and Food Safety. He is a lawyer, graduated in Portugal, and has been legal adviser for the Lisbon City Council.
From 2007 to 2009 he has been Chair of the National Jurisdiction Council of the Partido da Terra (Earth Party) and from 2009 to 2011 Secretary General of the Earth Party. He is also a member of the MEPs Interest Group “European Patients’ Rights & Cross-Border Healthcare”.


Medicines for Europe

John Hodgson

Executive Director, Editor In Vivo - Informa Pharma Intelligence

John Hodgson is Executive Editor at Informa, working for Scrip Intelligence and In Vivo. He has been a commentator on the biotechnology and healthcare industries for over 35 years, first as a science editor (Trends in Biotechnology, Nature Biotechnology) and then as a consultant (clients included the European Commission and UK government, venture-backed start-ups, multinationals in pharmaceuticals and agriculture, and industry associations). He currently explores disconnections between science and industry, between announcements and delivery, and between words and numbers.


Medicines for Europe

Enrique Ordieres

President of Laboratorios Cinfa and Infarco

Enrique Ordieres is a pharmacist and an advocate of the role played by these health professionals and the pharmaceutical industry; he has been working in this sector for 27 years. For over a decade he has chaired Cinfa, the leading laboratory in terms of amount of medicines dispensed in Spanish pharmacies, which is presently undergoing a diversification and globalization process. He also chairs the parent company, Infarco, which likewise encompasses other health companies, including Cinfa Biotech, 3P Biopharmaceuticals and Cyndea Pharma, developers and manufacturers of chemical and biotechnological drugs. Graduated in Pharmacy, he has an MBA and a postgraduate degree in Dermo-Pharmacy, among other additional academic training. He has been a pharmacy owner and has chaired the Pharmacists’ Professional Association of Vizcaya and of the Basque Country, as well as being co-author of various books and publications, and a regular lecturer at various congresses and conferences.


Medicines for Europe

Jeremy B. Desai

CEO – Apotex Inc.

Jeremy was born in London, UK and gained a Pharmacy degree in 1981 followed by a PhD in 1985. He has spent over 30 years in progressively senior roles in the pharmaceutical industry. In 2014 he was appointed as CEO Apotex based in Toronto, Canada, having joined the company in 2003 as the Global Head of R&D.


Medicines for Europe

Frances Cloud, CFA

Founder – Pharmacloud

Frances Cloud runs her own consultancy, Pharmacloud, which is focused on generics and off-patent brands. She founded Pharmacloud after a 20+ year career in the City, as a pharmaceutical analyst and an M&A adviser. Pharmacloud’s activities span commercial due diligence, market mapping and market entry strategies, market modelling, strategic consulting and M&A support. Clients range from big pharma to small start-ups and also encompass a broad range of private equity funds. Recent transactions for which Pharmacloud has provided commercial due diligence include Doc Generici (Italy), Ethypharm (France), Martindale (UK, working for Ethypharm) and Stada (Germany, working for Cinven).
Frances Cloud holds a BA in Biochemistry from Magdalen College, Oxford and is a CFA charterholder.


Medicines for Europe

Randall Stanicky, CFA

Managing Director - RBC Capital Markets

Randall Stanicky, CFA, is a Managing Director at RBC Capital Markets. Randall has been head the RBC Specialty Pharmaceuticals team for the past three years covering global generic manufacturers and specialty therapeutic providers. He is a regular Wall Street speaker at international conferences and ranked Runner-up (RU) in the “Institutional Investor” poll this past year. Prior to RBC, he spent most of his career at Goldman Sachs, where as a Vice President in Global Investment Research, his coverage spanned specialty pharmaceuticals, drug distribution, pharmacy benefit managers, healthcare technology and the contract research organization sectors. Randall also served as a Managing Director at Canaccord Genuity and prior to joining the sell-side he was an analyst at Citigroup Global Asset Management assisting in the investment recommendations of healthcare stocks. He is also an active member and head of the audit committee of the Board of the Director of the Children’s Tumor Foundation and previous Board member of TherapeuticsMD (TXMD). Randall lives in New York City with his wife and two children.


Medicines for Europe

Simon Goeller, Dr.

Partner - Mckinsey & Company

Simon Goeller is a Partner based in Munich and the global leader of McKinsey's Generics Practice. Since joining McKinsey in 2002, Simon has worked for clients around the world on topics related to generics, branded generics, LOE management, pharma distribution and retail. He serves pharmacos, wholesalers, retailers/pharmacy chains, and PE firms. His recent experiences include global strategy and portfolio definition for a leading player in Branded Generics, pricing and market access efforts for various off-patent pharma and branded companies, field force optimization effort for generics player in Eastern Europe, post-merger integration and brand positioning for retail pharmacy chain, global strategic purchasing strategy for major U.S. healthcare company, lead and expert on various private equity and industry due diligences in healthcare, marketing & sales excellence programs for pharma companies across Europe, Japan, and the US, including specialty players and dermatology, definition of one of the largest global healthcare provider partnerships, consumer health and branded generics growth strategies globally. Prior to joining McKinsey, Simon obtained a B.A and M.Sc in Economics and Management Research from the University of Oxford (U.K.), and a PhD in Health Care Economics from the University of Giessen (Germany).


Medicines for Europe

Rafael Enrique Maciel Martínez

President – AMEGI

Surgeon, graduated from Universidad Nacional Autónoma de México (UNAM), Degree in Pharmacology. With experience in the pharmaceutical industry for more than 30 years, companies such as The Upjohn company, Boehringer Manheimm. Roche-Biotechnology and the last 14 years in the field of generics with Apotex. Throughout the period he has held positions such as; Director General, Marketing and Sales, Research and development, as well as medical and regulatory areas. President of the Mexican Association of Generics AMEGI since 2007.


Medicines for Europe

Jean Mina

Associate Partner – McKinsey & Company

Jean Mina is an Associate Partner in the Geneva office of McKinsey and Company.
Jean is a leader of McKinsey Pharmaceuticals and Medical practice.
In particular, Jean drives McKinsey’s knowledge effort and client activity in emerging markets globally, with focus on Sub-Saharan and North Africa. Jean has extensively served leading pharmaceuticals companies across emerging markets on topics ranging from growth strategy and market entry, to go-to-market and broader business model innovation. Recent experience include emerging markets market entry, strategic planning for large pharma multinational, generics growth strategy in Africa, business model innovation in Latin America, Asia and Africa. Jean is a published author on pharma in emerging markets. He holds an MBA from Columbia University in New York, USA and an engineering degree from the University of Toulouse in France.


Medicines for Europe

Abdallah Mazahreh

Marketing Director/MENA & Emerging Markets – Pharma International Company

Holds a Bachelor in Pharmacy (1995) and an MBA degree (2002) from University of Jordan. Mr. Mazahreh started his 22 years’ experience since 1995 and has taken different strategic positions within the different multinational companies. He led local, regional and global functions in sales, business development, launch, market access and marketing. He worked for companies as GlaxoSmithKline Middle East Pharmaceuticals (1995-2002), Ferring Middle East Pharmaceuticals(2003-2009) and Bayer EMEA HealthCare Pharmaceuticals(2010-2014). In 2015 he moved to generic industry as the Corporate Marketing Director for Dar Al Dawa a generic company in the MENA region. As from January 2016, Mr. Mazahreh joined Pharma International Company, a rising star and a fast growing generic company in the MENA region as Director of Marketing heading the marketing function in the MENA and emerging markets.
Mr. Mazahreh has extensive cross cultural experience and markets understanding within the MENA and emerging markets region in addition to different global markets exposure. Skilled in effective sales management, strategic marketing management, launch and market access excellence, leadership and cross cultural team management.
Additionally, Mr. Mazahreh has extensive certifications and business trainings from different international institutions such as Management Center Europe, Japan Leadership Academy, KPMG International, Vlerick Business School, UK Institute of Sales and Marketing and others.


Medicines for Europe

Vivian Frittelli

CEO – NAPM

Vivian Frittelli has been involved in the pharmaceutical industry for over a quarter of a century. He headed Hoffmann La Roche’s Marketing and Sales Division in South Africa before doing a stint as Country Manager for Roche in Saudi Arabia. Upon returning to South Africa he was appointed Regional Director of an NGO, The Smile Train, where he worked to provide subsidized surgeries for children with Cleft lips and palates throughout Southern Africa. Thereafter, he joined Sandoz Pharmaceuticals to establish their oncology division in the Country. Three years ago he joined the National Association of Pharmaceutical Manufacturers as the Chief Executive. The Association represents generic and biosimilar medicines manufacturers and is responsible for communicating to stakeholders and lobbying with government on behalf of members. He is a member of the management committee of the IGBA.


Medicines for Europe

Dilip G Shah

Secretary General – IPA

Mr. Dilip G. Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 50 years of varied experience in the pharmaceutical industry. He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicines and several other international meetings and conferences. He was a Member of the official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014. Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Member of the Expert Review Committee of Access to Medicine (ATM) Index (www.atmindex.org); Member of the CPhI International Advisory Board; Member of the Board of Advisors of Pharmabiz.com (Weekly); and Member of Task Forces and Expert Groups constituted by the Government of India for accelerating growth of the Indian pharmaceutical industry. He was Chair of the International Generic Pharma- ceutical Alliance (IGPA) for two terms (2005-07) and (2010-11). Mr. Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd, Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group (www.vision-india.com), a firm specialized in strategic planning. Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years.


Medicines for Europe

Keh Song Hock

Executive Director – Malaysian Organisation of Pharmaceutical Industries (MOPI)

Graduated with a Bachelor of Pharmacy degree from the University of Singapore in 1971. Served 30 years in the Malaysian public sector, 27 years with the Ministry of Health and 3 years on secondment as a Senior Research Officer with the National Scientific Council for Research & Development, Ministry of Science, Technology & Environment. Held various positions when in the Ministry of Health including Secretary to the Pharmacy Board, Medicines Advertisements Board, and the Ministry of Health Drug Formulary Panel. Retired as the Deputy Director of Pharmaceutical Services, Ministry of Health Malaysia in 2001. Joined the Pharmaceutical Association of Malaysia (PhAMA), an organization representing the innovative medicines industry and served as its Executive Director for 12 years from 2001 to 2012 and as advisor in 2013. Joined the Malaysian Organisation of Pharmaceutical Industries (MOPI), an organization representing the generics and biosimilars manufacturers in 2014 as Executive Director and has held this position since.


Medicines for Europe

Talgat Nurgozhin MD, PhD, DSc, Professor

Director of Center for Life Sciences – “National Laboratory “Astana”, Nazarbayev University

Nurgozhin Talgat graduated in 1992 from the Military Medical faculty at the Tomsk State Medical University. In 2002 he trained in Pharmacoepidemiology at the Boston University School of Public Health (USA) and participated in a seminar on ‘Medicine Policy Issues for Developing Countries’ organized by the World Health Organization and the Boston University School of Public Health in Beirut, Lebanon. He also did a continuing education course on ‘Economics, Policy and Administration’ in the Department of Medical Administration of the University of Virginia Commonwealth, Richmond, USA (2007).
From 2006-2009 he worked as a Vice Rector of the organizational and economic work, Almaty State Institute of Postgraduate Medical Education and was Professor of the Clinical Pharmacology Department. From 2009 -2011 he worked as a Managing Director of the National Medical Holding and since 2009 he has been the Deputy Director of the Healthcare Development Institute. From 2011 to 2015 he has been working at the "Nazarbayev University", Center for Life Sciences, as a Head of the Department of the Translational Medicine, Healthy Ageing and Global Health and Director of the Institute of experimental and clinical Pharmacology. Since 2016 - Director of Center for Life Sciences, “National Laboratory Astana” at Nazarbayev University. Professor Nurgozhin T participated in the development of the National Health Reform Program "Densaulyk" for 2016-2019 on the reform of the pharmaceutical health sector. He contributed to the development of the first Lists of Essential Medicines for Kazakhstan. Professor Nurgozhin introduced formulary system into practical health care to control the proper use of medicines. Participated in the development and creation of the Kazakh National Formulary and he is the editor-in-chief. Professor Nurgozhin member of the National Formulary Committee of the Ministry of Health and Social Welfare. Since 2016, he is the member of the commission to unite the quality of medical services at the Ministry of Health. Vice-President ISPOR Kazakhstan Regional Chapter.
For special merits in the health protection of the population of the Republic of Kazakhstan he was given an award pin as a grade «A» person in Health Affairs of the Republic of Kazakhstan (2005). He was also honored with a badge “For distinguished contribution to the development of health of the Republic of Kazakhstan” (2011). For achievements in the field of science he received an award pin «For merits in Science Development for the Republic of Kazakhstan» (2011, 2015). Prof. T. Nurgozhin is the author of more than 150 scientific works, seven monographs and eight predpatents and is a member of the editorial boards of the Consilium journal (2004), Big Guide of Medicines of the Moscow publishing house «Geotar-Media» (2011) and the Russian Pharmacoeconomics journal.


Medicines for Europe

Belinda Wood

CEO – Generic and Biosimilar Medicines Association (GBMA), Australia and Vice-Chair of the IGBA Biosimilars Committee

Biography see above.


Medicines for Europe

Maggie Dolan

Regional Pharmacy Procurement Specialist – NHS Commercial Solutions Surrey

Biography see above.


Medicines for Europe

Gillian Woollett

Senior Vice President and Head FDA Policy and Regulatory Strategy Practice - Avalere Health

Gillian Woollett, M.A., D.Phil., SVP at Avalere, leads the FDA Policy and Regulatory Strategy Practice at Avalere, an advisory services firm of over 250 people that supports clients throughout the healthcare system, from patients to biopharma companies and payers/providers. At Avalere she provides the “prequel” of scientific and technical expertise that supports drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful in the public and private reimbursement world. She launched the FDA Practice in 2012. Dr. Woollett and her Team translate into practical action all aspects of regulatory engagement strategy and policy development relevant to commercial success for multiple multi-national clients. Concurrently, she created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with over 20 now having used this stepping stone to transition careers.
Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel & Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at PhRMA, where her group led, for example, on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity). At both trade associations, Dr. Woollett managed the interface between bio/pharma companies and the US Government in a manner that enabled their collective ability to expedite product development but without invoking any concerns of anticompetitive activity. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biological weapons issues.
Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as domestic, regulatory and scientific issues. She has been an appointee on Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She is currently represents biotechnology on the Material Technical Advisory Committee (MTAC) at the Department of Commerce (requiring a Secret Security clearance), and chairs the Biotech Work Group that addresses export controls and the Biological Weapons Convention, among other issues. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT), and on the Board of the Pharmaceutical Education Research Institute (PERI).
Gillian earned her B.A., M.A. in the Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the UK. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. She is well published in the peer reviewed literature.


Medicines for Europe

Suzanne McGurn

Assistant Deputy Minister and Executive Officer – Ontario Public Drug Programs

Suzanne is the Assistant Deputy Minister (ADM) and Executive Officer (EO) for the Ontario Public Drug Programs. In this role, she oversees one of the largest drug programs in North America, providing access to prescription medications for nearly 4 million Ontarians. Her position immerses her in the conversation about pharmaceuticals from all perspectives – patients, clinicians, manufacturers (generics/brands/biosimilars), pharmacists and pharmacy sector, research, innovation, health system and the list goes on.
Suzanne also plays a significant leadership role within the pan-Canadian Pharmaceutical Alliance (pCPA). Through its efforts the pCPA is bringing improved value to the publicly funded drug plans across Canada, harnessing the negotiating power of 14 participating jurisdictions with its emphasis on not only affordability but also greater consistency in access and appropriateness. In addition to the pCPA work, the Ontario Public Drug Programs is an important part of Ontario’s broader efforts to address other key public policy challenges through initiatives such as: the pharmacy naloxone program, reduction in access to high strength opioids, the patch for patch program, access to medications for MAID (Medical Assistance in Dying), expansion of access to Hepatitis C drugs and increased access to medications for low income seniors. All of these initiatives having launched during the past year.
Suzanne brings over 30 years of experience in the health care environment to bear in the work she does – half of that time spent in various clinical and management positions as a nurse and half of the time spent in public service. Her education reflects a similar split as a graduate of Queen’s University with both a Bachelor of Nursing Sciences and a Masters of Public Administration.
In addition to her enthusiastic approach to her current role, she is also passionate about her family and enjoys her weekend trek home to Tamworth, a small farming community north of Napanee and time spent with her family including two grandchildren.


Medicines for Europe

Hiroyuki Sakamaki, MBA, Dr Med Sci.

Professor – Tokyo University of Science

Hiroyuki Sakamaki is the professor for the Tokyo University of Science, School of Management. He is also the visiting research scientist for the Institute for Health Economics and Policy (IHEP) that is a non-profit corporation approved by the Ministry of Health, Labour and Welfare (MHLW). His specialties are health technology assessment including pharmacoeconomics and health expenditure analysis. He works research projects related to pharmaceutical policy, most of the researches are used as the basis for the discussion of healthcare system reforms. He graduated from Faculty of Pharmaceutical Science Hokkaido University (1978), Keio Graduate School of Business Administration (Business School, 1992). He received a Doctor Degree of Medical Science from Keio University. (2006)


Medicines for Europe

Florian Turk

Global Head Payor Marketing, Sales and Engagement - Sandoz and Vice-Chair Market Access Committee - Biosimilar Medicines Group, a Medicines for Europe Sector Group

Prof. Dr. Florian Turk is the Global Head Payor Marketing, Sales and Engagement at Sandoz Biopharma. He has more than 15 years of global pharmaceutical and generics industry experience. Prior to joining Sandoz, Florian held several roles responsible for business-to-business commercialization, market access, pricing, public affairs and health economics in Novartis Pharmaceuticals and GlaxoSmithKline. Florian also holds responsibilities as Honorary Professor at the Department for Management, University of Paderborn. Florian holds a Master of Science in Economics and a Doctorate in Business Administration from the University of Trier in Germany.