Medicines for Europe Medicines for Europe

CHAIRPERSONS AND SPEAKERS

Medicines for Europe

Christoph Stoller

Senior Vice President Teva and President Medicines for Europe

Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe. In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility 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 (lic.oec.HSG).

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. Adrian is also the President of the European Medicines Verification Organisation (EMVO) for the implementation of serialisation against falsified medicines. 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

Andrzej Rys

Director Health Systems, Medical Products and Innovation, DG SANTE - European Commission

o Member of IMI Governing Board
o Alternate Member of the European Medicines Agency (EMA) Board
o Medical doctor specialized in radiology and public health, graduate of Jagiellonian University, Krakow (Poland).

Professional Experience:
• 2011: Director for Health Systems, Medical Products and Innovation in the Directorate-General for Health and Food Safety, European Commission
• 2006: Director for Public Health and Risk Assessment in the Directorate-General for Health and Consumers, European Commission.
• 2003: Founder and Director of the Center for Innovation and Technology Transfer at Jagiellonian University (Krakow, Poland).
• 1999-2002: Deputy Minister of Health in Poland. Member of the Polish accession negotiators team.
• 1997-1999: Director of Krakow’s city health department.
• 1991-1997: Founder and Director of the School of Public Health at the Jagiellonian University.

Medicines for Europe

Guido Rasi

Executive Director, EMA

Professor Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, Professor Guido Rasi served as EMA’s Principal Adviser in Charge of Strategy.
From November 2011 to November 2014 he was the Executive Director of the European Medicines Agency and a member of its Management Board in the three years prior to this.
He has been elected Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) from 1st October 2019 for a term of 3 years.
He was Director-General of the Italian Medicines Agency from 2008 to 2011 and member of the Management Board from 2004 and 2008.
He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008.
From 2005 to 2008 he was Director of Research at the Institute of Neurobiology and Molecular Medicine of the National Research Council (CNR) in Rome.
From 1990 to 2005 Professor Rasi worked at the Institute for Experimental Medicine of the National Research Council, Italy.
He had a teaching and research experience at the University of California, Berkeley in 1999.
Professor Rasi holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome.
From 1978 to 1990, he worked as a physician in hospital, research and private practice. He is author of more than 100 scientific publications.
Prof Rasi was born in Padova, Italy and is married with two children.

Medicines for Europe

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA) (IE) a member of the Heads of Medicines Agencies (HMA) Management Board

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA) and the EU HMA Management Group. Ms Nolan was recently appointed to the role as vice-chair of the EMA.

Medicines for Europe

Rúna Hauksdóttir Hvannberg

Executive Director, Islandic Medicines Agency IMA (IS)

WORK EXPERIENCE
February 2015 – Present: Executive Director
Icelandic Medicine Agency (Iceland)
Head of Agency
September 2007 – February 2015: Chairman
Icelandic Medicine Pricing and Reimbursement Committee Pricing and Reimbursement
EDUCATION AND TRAINING
September 2003 – June 2005: MSc. Health Economics
University of Iceland
Economics and Health Economics
September 1987 – July 1989: MSc. BioPharmacy
University of London (United Kingdom)
Bioavailability clinical pharmacology
September 1982 – June 1987: Msc. Pharmacy
University of Iceland
Post and undergraduate pharmacy

Medicines for Europe

Prof. Dr. med. Karl Broich

President, BfArM, (DE)

Mr. Prof. Dr. Karl Broich was born on 1st October 1959 and absolved a Study of Human Medicine at the Medical Faculty of the Rheinische-Friedrich-Wilhelms-Universität Bonn from 1979 till 1985.
Since 2014, Mr. Prof. Dr. Karl Broich is President of the Federal Institute for Drugs and Medical Devices in Bonn. Previously, he was Vice President of the Federal Institute for Drugs and Medical Devices from 2009 – 2014.
His Scientific focus is clinical psychopharmacology; advanced imaging in neurodegenerative diseases, biomarkers, dementia, and methodology of clinical trials. In addition, Mr. Prof. Dr. Karl Broich is author and co-author of over 180 essays (original scientific papers, reviews, book contributions).

Medicines for Europe

Beata Stepniewska

Deputy Director General and Head of Regulatory Affairs, Medicines for Europe

Beata Stepniewska is Deputy Director General, Head of Regulatory Affairs of Medicines for Europe in Brussels. In this position, she is responsible for coordinating the regulatory and scientific activities, covering a variety of EU and international regulatory developments. She is also responsible for the coordination of several internal Committees and Working Groups, including the Regulatory and Scientific Affairs Committee. She is also a member of the ICH Management Committee and the ICH General Assembly on behalf of the IGBA (International Generic and Biosimilar medicines Association). Having worked with the Medicines for Europe (formerly EGA) since early 2002, Beata has been involved in expressing the position of the generic medicines industry to the European Commission, Parliament and Council as well as the CMDh, the EMA and National Competent Authorities on a number of pieces of legislation and on many regulatory guidelines related to marketing authorization. In her previous position as the Regulatory Affairs and EU Accession Manager, she was responsible for building a regulatory dialogue between the EU and authorities and industry of South East European Countries (Croatia, B&H, Serbia, Kosovo, Montenegro and Turkey) to increase the level of regulatory harmonisation between the EU and non EU countries and to facilitate operational activities of EGA members on both EU and non-EU markets. Before joining the EGA, Beata was Head of the Regulatory Affairs Department of PLIVA Krakow (currently a part of the TEVA group) and Regulatory Intelligence Manager for the PLIVA Group. Before joining the generic medicines industry, she worked as a University researcher and lecturer at the Faculty of Pharmacy in Krakow (Poland) as head of Department of Pharmaceutical Law and Pharmacoeconomics. She is a qualified pharmacist.

Medicines for Europe

Caroline Kleinjan

Chair of the Regulatory and Scientific Affairs Committee Medicines for Europe, Sandoz

Nationality: Dutch
University Education:
1980-1986: University of Leiden Pharmacy, Graduated as pharmacist
1987: University of Utrecht Pharmacy, Graduated as public pharmacist Working experience: 1988-1990: Pharmacist in a public pharmacy
1990-1992: QA Manager, Multipharma B.V. (now rebranded into Sandoz B.V), the Netherlands Education as QP, acting as QP for Modipack (packaging company, owned by Ciba-Geigy B.V)
1993-1994: Regulatory Affairs Manager, Multipharma B.V. (now rebranded into Sandoz B.V.), NL
1995-2004: Subsequently Technical Affairs Associate, Registration Manager and Head of the Centre for Generic Drug Registration Europe, Novartis Generics
Since 01-01-2005 Head Regulatory Competence Centre Europe, Sandoz.
This department is responsible for all new submissions in geographical Europe within the Sandoz organization and subsequent maintenance of the marketing authorization till launch of the product. After launch the marketing authorization maintenance is moved to a dedicated maintenance team.

Medicines for Europe

Koen Laenen

Regulatory Affairs and Quality Manager, Medicines for Europe

Koen Laenen joined Medicines for Europe in November 2018 as Regulatory Affairs and Quality Manager. Prior to Medicines for Europe, Koen was Business Unit Director at Ardena NV leading a team of CMC writers and Regulatory Affairs Officers from 2015 till 2018. Prior to that Koen was working for +10 years for Jubilant Pharmaceuticals NV as Head of Operations. In this function he was overlooking the performance and deliveries of the R&D projects, Site Transfers and Bio-Equivalence Studies to ensure that the planned deliverables were executed on time. And to manage the Regulatory Affairs and Quality Assurance departments in Europe, to timely obtain and maintain all market. Koen has a university degree in biotechnology and prior to starting in the pharmaceutical business he worked for several years as researcher in molecular neurobiology at university of Ghent.

Medicines for Europe

Esther Martinez

Scientific Administrator Manufacturing Quality and Supply Chain Integrity, Committees and Inspections, EMA

Esther Martinez joined the European Medicines Agency in January 2011. She has since held various roles including co-ordination of GMP inspections and assessments of quality defects and product recalls.
Ms Martinez is currently part of the GMP/GDP Inspectors Working Group secretariat. In addition, she is the EMA business liaison for EudraGMDP and the interface between the European Commission and EMA with regard to the implementation of the EU Falsified Medicines Directive. Since August 2018, she is the co-chair of the working group on supply chain disruptions of the EMA/HMA Task Force on Availability of Authorised Medicines.
Esther obtained her degree in Chemistry from the University Autonomous of Madrid in Spain. She holds an Advanced Studies Diploma in Chemistry as a Multidisciplinary Science and a Postgraduate Certificate in Pharmaceutical Medicine (Drug Development Science) from King’s College London. In 2017, she completed her Qualified Person training at University College London.

Medicines for Europe

Laure Geslin

Head of Division Proper Use, FAMHP (Belgium)

Biography soon available.

 

Medicines for Europe

Valerie Jensen

Center for Drug Evaluation and Research (FDA)

CAPT Valerie Jensen is Associate Director of the Drug Shortage Staff at the U.S. Food and Drug Administration. She received a B.S. degree in Pharmacy from the University of Iowa in 1990. She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991. She worked as a clinical pharmacist for Indian Health Service hospitals in Arizona and New Mexico before joining FDA in 1999. She was one of the initial developers of FDA’s Drug Shortage Program and was named Associate Director in 2012.

Medicines for Europe

Giorgio Ricco

TEVA

Biography soon available.

 

Medicines for Europe

Geraldine Moore

Senior Registration Manager, Mylan

Geraldine Moore is a pharmacist by training and has over 17 years’ experience in Regulatory Affairs within the generics industry and is currently a Senior Registration Manager at Mylan. She is also a member of the Medicines for Europe Brexit Task Force and the Joint Life Science Industry Coalition on Brexit.

Medicines for Europe

Susanne Winterscheid

BfArM (DE)

Susanne is biologist and started at the BfArM in the variation section after a few years of employment in pharmaceutical industry. Since 2005 she was heading the Project Management of a licensing division at BfArM. Since 2008 she is Chair of the Joint CMD working party for variations and member of the EU Variation Task Force. In November 2011 she has become the German member of the CMDh. Since June 2015 she is Head of Licensing Division 3 at BfArM.

Medicines for Europe

Hélène Bruguera

EDQM

Mrs Hélène BRUGUERA graduated in Biochemistry from the University of Nancy, France and has a Master in Industrial Pharmacy from the University of Strasbourg, France. She worked for the pharmaceutical industry for 10 years in analytical development and in the preparation of the quality part for marketing applications. She joined the EDQM in year 2000, and is currently the Head of the Certification Department. She deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and APIs (ICH) and is currently co-chair of the IPRP Quality Working Group of Generics.

Medicines for Europe

Florian Schmidt

DG SANTE

Florian Schmidt is the deputy head of unit of the Commission's pharmaceutical unit B.5 in the Directorate-General for Health and Food Safety (DG SANTE). He is a lawyer by training and joined the Commission in 2004. Amongst other things, he was involved in the implementation of the new pharmacovigilance legislation and followed the paediatric regulation, as well as general legal matters and court cases.

Medicines for Europe

Astrid Krupp

Vice President Regulatory Affairs, Business Unit Generics and Complex Formulations ELAMA & Asia Pacific, Fresenius Kabi Deutschland GmbH

Astrid Krupp is currently heading one of the regulatory affairs departments of Fresenius Kabi and is in this position responsible for the definition of best regulatory strategies for development and registration of new products and maintenance of existing portfolio globally. Astrid Krupp holds a degree as state-certified food chemist from the TU Braunschweig, Germany. She started her career 1999 working in the regulatory affairs department of a small privately-owned company that soon underwent several mergers and finally became the leading generics affiliate of Sanofi in EU. She then joined Fresenius Kabi in 2007 to broaden her scope and work globally. Her focus is on regulatory strategies and CMC and since 2011 she is part of the Regulatory and Scientific Affairs Committee of Medicines for Europe.

Medicines for Europe

Sarah Faircliffe

Legal Director, Bird & Bird

Sarah is a Legal Director in Bird & Bird's London office. As a member of the firm's International Life Sciences Group, she specialises in European regulatory law concerning medicinal products, medical devices and related areas.
Sarah offers unique insight into the law and procedures concerning the regulation of medicines, having spent 10 years as Legal Adviser with the European Medicines Agency (EMA). During her time at the EMA, she advised on many areas, including orphan drugs, paediatrics and generics of centrally authorised products, as well as advising the EMA's scientific committees on legal issues.
She also played a key role ensuring that the new EU member states joining in 2004 brought their pharma legislation and procedures into line with EU requirements. Working closely with the European Commission, she assisted with a number of pieces of litigation and the drafting and implementation of various pieces of legislation.
Since joining Bird & Bird, Sarah has assisted a wide range of clients on all aspects of the regulation of products in the life sciences sector. This ranges from advising on the correct interpretation of legislation, guidelines and case law to helping to steer clients through procedures and negotiations relating to the marketing of their products, including representing them in discussions with regulatory bodies. Strategies and disputes concerning regulatory data protection and orphan exclusivity are a particular focus of her current work, with two ongoing cases in the EU General Court.
Sarah is a regular speaker at conferences and workshops and contributes to a number of publications. She is co-chair of Bird & Bird's Life Sciences Regulatory Group.

Medicines for Europe

Koosje van Lessen Kloeke

Leijnse Artz

Biography soon available.

Medicines for Europe

Sonia Ribeiro

EMA

Biography soon available.

Medicines for Europe

Susana Almeida, PhD

Clinical Development and Safety Director, Medicines for Europe

Dr. Susana Almeida is Quality and Clinical Development Director at Medicines for Europe (formerly EGA). Before joining Medicines for Europe, Susana was the Chair of the Bioequivalence Working Group for almost 15 years. She has worked in the clinical trials field in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organisations. She has overseen the conduction of dozens of clinical trials carried out in Europe, North and South America and Asia. At Medicines for Europe, Susana is responsible for the coordination of the Bioequivalence and Clinical Development Working Group, the Pharmacovigilance Working Group and Workstreams, and of the Medical Device Task Force She is a Topic Leader representing IGBA in the drafting committee of the International Council for Harmonisation (ICH)'s M09 topic. She holds a PhD in Clinical Pharmacology from the Faculty of Medicine, Universidad Autònoma de Barcelona (UAB), Spain and has authored several scientific papers in the field of clinical trials.

Medicines for Europe

Nivedita Valentine

Accord Healthcare

Biography soon available.

Medicines for Europe

Pavel Farkas

Senior Director Global Generics Clinical R&D, Teva

Pavel Farkas graduated and earned a Doctor of Pharmacy degree from J.A. Comenius University and Institute of Experimental Endocrinology of Slovak Academy of Sciences in Bratislava, Slovakia, completed a specialization degree in Clinical Pharmacy at the National Institute of Oncology in Bratislava, Slovakia and Pharmaceutical Medicine at the Charles University in Prague, Czech Republic. He joined the generic pharmaceutical industry following a career in the field of basic pharmacological and endocrinological research and has been working in the area of clinical development of generic products for over 20 years. He joined PLIVA in 2004 with responsibilities and experience covering pharmacokinetic, bioequivalence and therapeutic equivalence studies for generic products, conducted mostly for EU/CEE, US and Canadian regulatory submissions as well as respective GCP and regulatory aspects. Pavel Farkas is currently responsible for PLIVA/TEVA’s R&D Biopharmaceutics operations, acting as a member of the Bioequivalence Working Group of Medicines for Europe and Steering Committee of AAPS Generic Pharmaceutical Focus Group.

Medicines for Europe

Augusto Filipe, Dr. MD

Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

  • Member of the Portuguese Medical Association.
  • Head of Medical Departmet of Farmoz/Grupo Tecnimede, Portugal.
  • European Union Qualified Person for Pharmacovigilance (EU QPPV).
  • Member of the Eudravigilance Expert Working Group (EV-EWG).
  • Member of Medicines for Europe - Pharmacovigilance and Safety Working Group (PhVWG).
  • Published severals scientific papers in peer review journals (areas of interest: clinical trials, pharmacovigilance and safety, respiratory diseases).

Medicines for Europe

Jan Welink

MEB (NL)

Biography soon available.

Medicines for Europe

Fakhredin Sayed Tabatabaei

MEB (NL)

Fakhredin Sayed Tabatabaei is a medical doctor and an epidemiologist. He works as a senior assessor at the pharmacovigilance department of the Dutch national agency (MEB) for almost 14 years, and has been involved in May processes regarding Patient Information documents. Since 2017, he is participating in the 'Better Use programme,' initiated within the Dutch agency, focusing on improving access to product information, so that both patients and healthcare providers can search for, find, consult and use information about medicines.

Medicines for Europe

Anjana Pindoria

Extedo

+ 15 years of experience in Regulatory Affairs and special programmes, ranging from writing MAA applications, Implementation of eCTD; XEVMPD, and multiple company integration of global product acquisitions.
• Proactive Member of the SPOR Substance Subgroup and the ISO IDMP Taskforce.
• Co-chair of the IAFT ePI Working group
• Member of the Medicine for EU Digital Taskforce.
In 2016 Anjana started working within EXTEDO's Product Management Team. Her role enables her to listen to the industry pains as well as scanning the horizon for future changes that could impact the way we work today.

Medicines for Europe

Juan García-Burgos

Head of Public Engagement Department, European Medicines Agency (EMA)

Juan Garcia Burgos is a Qualified Medical Doctor from the University of Autonoma in Madrid, specialised in urology. Juan worked as an urologist surgeon at the hospital Gregorio Maranon in Madrid. He joined the European Medicines Agency in 2002 in the scientific Units and was responsible for coordinating the preparation of EU clinical guidelines for drug development. He took up new responsibilities in 2005 where he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and HealthCare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences.
In January 2017, he was appointed Head of Public Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

Medicines for Europe

Georg Neuwirther

Head of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)

Georg Neuwirther joined the Austrian Agency of Health and Food Safety in 2003. He was responsible for real estate management before holding different management positions in IT. In 2014 he was appointed Head of IT of the division “Austrian Medicines and Medical Devices Agency (AGES MEA)” after the successful migration of the legacy drug information system to a new business solution. Georg Neuwirther is board member of the EU Telematics Management Board (EUTMB) and member of several telematics groups (e.g. ITDEC, TEAB, EUNDB, SPOR TF). As chair of the Electronic Application Form (eAF) Maintenance Group he is also leading the project CESSP Phase 1. In 2019, his IT and business expertise also contributed to the development of the draft roadmap for the introduction of the electronic product information (ePI).

Medicines for Europe

Peter Bachmann

Head 'International Liason Office and Conferences', Executive Department ‘European Union and International Affairs’, Federal Institute for Drugs and Medical Devices (BfArM), DE

Peter Bachmann has joint in 1999 the Federal Institute for Drugs and Medical Devices (BfArM, Germany), Department of ‘Drug Approval’. He was in the following years the head of several subunits and units responsible for the variation and authorisation of medicinal product in the framework of MRP, including the task of the German representative to the MRFG (Mutual Recognition Facilitation Group). Following the reorganisation of the BfArM in July 2005, Peter Bachmann was appointed as Senior Expert for ‘European Drug Regulatory Affairs’ at Department ‘European and International Affairs’. He was the appointed German CMDh member until November 2011 and served as elected CMDh Chair from November 2011 till November 2017. His current position is the Head of ‘International Liason Office and Conferences at BfArM, the German Member of the NtA, a member of the EUNDB and the SPOR Task Force, ), a member of the HMA WG ‘Better Use of Medicines’ (incl the ePI Task Force), a member of the International Pharmaceutical Regulators Programme (IPRP) Management Committee (since 2018), the European Lead of the ICH GDG (Generic Discussion Group) and member of different other European and International AdHoc Working Parties.. His is a lecturer for „Drug Regulatory Affairs‟ at several Universities (Bonn, Duisburg, Basel, Copenhagen), a Honorary Member of the Middle-European Society for Regulatory Affairs (MEGRA), a Honorary Lifetime Member of TOPRA, a former member and Vice-Chair of the DIA Advisory Committee Europe (2007 – 2013), DIA Board of Directors (2013 – 2016) and is currently serving at the DIA Council of Regulators and the TOPRA Advisory Committee.

Medicines for Europe

Kevin Airey

Director Regulatory Affairs EMEA Affiliates, Mylan

Kevin started his career in R&D specialising in Generic OSD formulations at Adcock Ingram Laboratories in South Africa. Subsequently and for 13 years, he worked as an affiliate in New Zealand for a subsidiary of Merck Generics and managed the regulatory and PV responsibilities for both the generic arm of the company and their agency companies, Alcon Laboratories, Galderma and Ferring AB, all of whom marketed their products in NZ through Merck Generics. In 2000, he moved back to the UK to learn about European regulatory submissions on a 18 months secondment and then accepted a permanent position with the Merck Generics regulatory management team in 2003. Kevin has also been an active participant of a couple of industry working groups over subsequent years. He was on the 'Centralised Procedure' working group within Medicines for Europe (EGA) who's role it was, to work with EMA to introduce the Centralised Procedure to the generic industry. Currently he's part of the 'ebooklet' working group within Medicines for Europe. Merck Generics was sold to Mylan in October 2007. In 2010 Kevin was seconded to Mylan Seiyaku, Tokyo Japan for almost 2 years, to mentor the newly appointed Regulatory and Pharmacovigilance Director before returning to the UK, to establish the 'Affiliate Support Team' for Mylan's Regulatory affiliates across the European region which is his current position.

Medicines for Europe

Britt Vermeij

TEVA

Britt graduated as Pharm.D. at the University of Utrecht. In 2001, she started working for Teva in the Regulatory Affairs Department of the Dutch commercial Business Unit. From 2005 she headed this department in Teva Netherlands. In 2009 she got the position of Regional RA Head, in which she was managing Western European Market RA departments in 11 countries. From 2012 on she changed to the role of European Regulatory Intelligence and Policy, which changed in April 2018 to her current role of Director Regulatory Affairs Projects and Policy implementation in which she is the EU RA project lead for implementation of EU projects like Brexit and FMD, participates in association projects like ePI and Variations, is doing assessment of new, revised or proposed legislation and providing EU Regulatory information throughout the company.

Medicines for Europe

Katarina Nedog

Head Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz

Katarina Nedog is Head Business Process & Excellence Information Management & Systems, global Regulatory Affairs at Sandoz since September 2018. In this role, she leads the functions responsible for creation and harmonization of IM&S business processes, IT system related training coordination and execution, submission resource planning and the teams responsible for central document processing.
Prior to Sandoz, Katarina worked for nearly 4 years at the Medicines for Europe - Brussels based trade association representing generic, biosimilar and value added pharmaceutical industries. Within the Regulatory and Scientific team, she coordinated the work of relevant working groups, represented the association and led multiple projects, covering pharmacovigilance, telematics, antimicrobial resistance and environment-related topics.
Katarina developed her passion for regulatory affairs during her position as Regulatory Affairs Manager at Sandoz between 2007 – 2013. Working in a dynamic, international working environment, she always strived to accomplish the most in a smartest way.
Katarina holds a bachelor’s degree in Pharmacy from University of Ljubljana, Slovenia.

Medicines for Europe

Stephanie-Kohl

Policy & Advocacy Officer, European Association of Hospital Pharmacist (EAHP)

Stephanie Kohl is the Policy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP) which represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. In her capacity as Policy & Advocacy Officer, Stephanie coordinates and supports EAHP’s engagement in policy discussions relevant to hospital pharmacists.

Medicines for Europe

Lei Zhang, Ph.D.

Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

serves as the Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. Dr. Zhang was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA. She is an accomplished professional with more than 21 years of combined experiences in the areas of drug research, development and regulatory review and approval. She has contributed to numerous guidance development and research projects focused on the science-based regulatory decision-making. Before joining FDA in 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, Schools of Pharmacy and Medicine. She has authored and co-authored numerous papers, book chapters, abstracts, and invited presentations in the area of clinical pharmacology and regulatory science. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is currently a Board member of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) and serves on the Clinical Pharmacology and Therapeutics Editorial Board. She is a member of the ICH Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Leader. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013.

Medicines for Europe

Luther Gwaza

WHO

Biography soon available.

Medicines for Europe

Remco Munnik

Associate Director, Iperion Life Sciences Consulting

+20 years in experience in Life Science and Regulatory Affairs, 10+ years consultancy with focus on Regulatory Information Management (RIM) and electronic submissions.
- Strategy & Project manager
- Subject Matter Expert for Regulatory Information Management systems (RIM), eCTD, xEVMPD and ISO IDMP
- Member of EMA ISO IDMP Task Force Organizations and Products
- Chair Medicines for Europe Telematics group (eAF, eCTD, CESP, xEVMPD and ISO IDMP)

Medicines for Europe

Isabel Chicharo

Head of Data and Information Lifecycle Management Service Deputy Programme Manager for the SPOR/IDMP Programme, EMA

Isabel is responsible for the implementation and management of a Master Data Management Service which will be used to manage Substances, Products, Organisations and Referential data (also known as SPOR). She coordinates operational aspects of the service as well as business aspects of the programme and reports directly to Francisco Penaranda the Head of Business Data and Analytics Department.
Isabel has a Pharmacy degree, a post graduate degree in Pharmaceutical regulation and 17 years of data management experience in the field of Medicines. Her experience has covered Software companies, a National Regulatory Authority as well as EMA. She has coordinated complex projects and teams on various EMA internal and international projects.
Specialties: Good knowledge of European pharmaceutical legislation and procedures.
Experience in information and data management, data quality assessment and control.

Medicines for Europe

Joris Kampmeijer

MEB

Biography soon available.

Medicines for Europe

Stuart Izod

Head Regulatory Information Management, Global Regulatory Affairs, Teva

Stuart and his team are responsible for Teva’s centralised registration data management and XEVMPD submissions operations. Also responsible for executing the global change programmes required to successfully implement the data management systems and processes required to comply with regulatory data standards and submission requirements (e.g. ISO IDMP) as they evolve globally.
Stuart has worked within Pharmaceutical R&D for more than 20 years, focussed mainly within big pharma Clinical and RA. This included leading the successful implementation of a foundational master data management solution as part of a major global change programme.

Medicines for Europe

Laura Oliveira Santamaria

Chair of the CMDh, AEMPS (ES)

Biography soon available.

Medicines for Europe

Kora Doorduyn-van der Stoep

Vice-Chairperson CMDh, NL-CMDh member/Senior Policy Adviser Medicines Evaluation Board (MEB) (NL)

She works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/ Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

Medicines for Europe

Jitka Vokrouhlická

SUKL (CZ)

Jitka Vokrouhlická graduated at the First Faculty of Medicine, Charles University, Prague. After graduation she worked as a clinical researcher in the Centre for Metabolic Bone Diseases in the General Teaching Hospital in Prague until joining the State Institute for Drug Control in 2008. From 2008 till 2010 Jitka Vokrouhlická worked as a Clinical Assessor and a Coordinator of European procedures in the State Institute For Drug Control, from October 2010 till December 2014 as the Head of Department of Marketing Authorisation Agenda and in January 2015 she was appointed the Head of Coordination and Regulation Department of the Marketing Authorisation Section at the State Institute For Drug Control. Jitka Vokrouhlická has been the Czech CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – human) member since January 2010.

Medicines for Europe

Ana López de la Rica Manjavacas

CMDh Member for Spain, AEMPS (ES)

Ana López de la Rica is the CMDh member representing the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain, where she currently coordinates regulatory affairs and standardisation tasks and started to work in 2008 performing Clinical assessesment. She is member of the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations serving the INN Expert Group and NCA Regulatory Liason (Alternate) representing AEMPS of the ISO-IDMP SPOR project coordinating by EMA. Before joining the AEMPS, Ana López de la Rica worked as Head of Regulatory Affairs in Noscira S.A. (Zeltia group) and before of that as a Regulatory Affairs Specialist in Lilly S.A. (Spain) from 2003 to 2008. After getting her Bachelor of Pharmacy in the Facultad de Farmacia, Universidad de Valencia (Spain) from 1996 to 2001, she has completed her education by performing a Master in Development, registration and regulation of medicines in the Universidad Autónoma de Barcelona (Spain) from 2002 to 2003 and a twoyear Master in Health Economics and Pharmacoeconomics in the Universitat Pompeu Fabra, Barcelona (Spain) from 2012 to 2014.

Medicines for Europe

Sabina Uzeirbegović

HALMED (HR)

Sabina joined Croatian Agency for Medicinal Products and Medical Devices (HALMED) in 2006, where she currently holds position of Principal Coordinator for Mutual Recognition and Decentralised procedures (MRP/DCP). Her main responsibilities include coordination and overseeing of regulatory procedures within the MRP/DCP in HALMED. She has been Croatian representative to Coordination group for Mutual Recognition and Decentralised procedures – human (CMDh) since the accession of Croatia to the EU, as well as representative to the NtA. She is also a member of several WG within the CMDh. She is a pharmacist with postgraduate specialty study in clinical pharmacy.

Medicines for Europe

19th REGULATORY AND SCIENTIFIC AFFAIRS CONFERENCE

30-31 JANUARY 2020

Medicines for Europe

Christoph Stoller

Senior Vice President Teva and President Medicines for Europe

Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe. In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities. Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017. Christoph has been working for Teva Europe in various roles with increasing responsibility 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 (lic.oec.HSG).


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. Adrian is also the President of the European Medicines Verification Organisation (EMVO) for the implementation of serialisation against falsified medicines. 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

Andrzej Rys, Dr

Director Health Systems, Medical Products and Innovation, DG SANTE - European Commission

o Member of IMI Governing Board
o Alternate Member of the European Medicines Agency (EMA) Board
o Medical doctor specialized in radiology and public health, graduate of Jagiellonian University, Krakow (Poland).

Professional Experience:
• 2011: Director for Health Systems, Medical Products and Innovation in the Directorate-General for Health and Food Safety, European Commission
• 2006: Director for Public Health and Risk Assessment in the Directorate-General for Health and Consumers, European Commission.
• 2003: Founder and Director of the Center for Innovation and Technology Transfer at Jagiellonian University (Krakow, Poland).
• 1999-2002: Deputy Minister of Health in Poland. Member of the Polish accession negotiators team.
• 1997-1999: Director of Krakow’s city health department.
• 1991-1997: Founder and Director of the School of Public Health at the Jagiellonian University.


Medicines for Europe

Guido Rasi

Executive Director, EMA

Professor Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, Professor Guido Rasi served as EMA’s Principal Adviser in Charge of Strategy.
From November 2011 to November 2014 he was the Executive Director of the European Medicines Agency and a member of its Management Board in the three years prior to this.
He has been elected Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) from 1st October 2019 for a term of 3 years.
He was Director-General of the Italian Medicines Agency from 2008 to 2011 and member of the Management Board from 2004 and 2008.
He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008.
From 2005 to 2008 he was Director of Research at the Institute of Neurobiology and Molecular Medicine of the National Research Council (CNR) in Rome.
From 1990 to 2005 Professor Rasi worked at the Institute for Experimental Medicine of the National Research Council, Italy.
He had a teaching and research experience at the University of California, Berkeley in 1999.
Professor Rasi holds a degree in medicine and surgery, with specialisations in internal medicine, allergology and clinical immunology, from the University of Rome.
From 1978 to 1990, he worked as a physician in hospital, research and private practice. He is author of more than 100 scientific publications.
Prof Rasi was born in Padova, Italy and is married with two children.


Medicines for Europe

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA) (IE) a member of the Heads of Medicines Agencies (HMA) Management Board

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA) and the EU HMA Management Group. Ms Nolan was recently appointed to the role as vice-chair of the EMA.


Medicines for Europe

Rúna Hauksdóttir Hvannberg

Executive Director, Islandic Medicines Agency IMA (IS)

WORK EXPERIENCE
February 2015 – Present: Executive Director
Icelandic Medicine Agency (Iceland)
Head of Agency
September 2007 – February 2015: Chairman
Icelandic Medicine Pricing and Reimbursement Committee Pricing and Reimbursement
EDUCATION AND TRAINING
September 2003 – June 2005: MSc. Health Economics
University of Iceland
Economics and Health Economics
September 1987 – July 1989: MSc. BioPharmacy
University of London (United Kingdom)
Bioavailability clinical pharmacology
September 1982 – June 1987: Msc. Pharmacy
University of Iceland
Post and undergraduate pharmacy


Medicines for Europe

Prof. Dr. med. Karl Broich

President, BfArM, (DE)

Mr. Prof. Dr. Karl Broich was born on 1st October 1959 and absolved a Study of Human Medicine at the Medical Faculty of the Rheinische-Friedrich-Wilhelms-Universität Bonn from 1979 till 1985.
Since 2014, Mr. Prof. Dr. Karl Broich is President of the Federal Institute for Drugs and Medical Devices in Bonn. Previously, he was Vice President of the Federal Institute for Drugs and Medical Devices from 2009 – 2014.
His Scientific focus is clinical psychopharmacology; advanced imaging in neurodegenerative diseases, biomarkers, dementia, and methodology of clinical trials. In addition, Mr. Prof. Dr. Karl Broich is author and co-author of over 180 essays (original scientific papers, reviews, book contributions).


Medicines for Europe

Beata Stepniewska

Deputy Director General and Head of Regulatory Affairs, Medicines for Europe

Beata Stepniewska is Deputy Director General, Head of Regulatory Affairs of Medicines for Europe in Brussels. In this position, she is responsible for coordinating the regulatory and scientific activities, covering a variety of EU and international regulatory developments. She is also responsible for the coordination of several internal Committees and Working Groups, including the Regulatory and Scientific Affairs Committee. She is also a member of the ICH Management Committee and the ICH General Assembly on behalf of the IGBA (International Generic and Biosimilar medicines Association). Having worked with the Medicines for Europe (formerly EGA) since early 2002, Beata has been involved in expressing the position of the generic medicines industry to the European Commission, Parliament and Council as well as the CMDh, the EMA and National Competent Authorities on a number of pieces of legislation and on many regulatory guidelines related to marketing authorization. In her previous position as the Regulatory Affairs and EU Accession Manager, she was responsible for building a regulatory dialogue between the EU and authorities and industry of South East European Countries (Croatia, B&H, Serbia, Kosovo, Montenegro and Turkey) to increase the level of regulatory harmonisation between the EU and non EU countries and to facilitate operational activities of EGA members on both EU and non-EU markets. Before joining the EGA, Beata was Head of the Regulatory Affairs Department of PLIVA Krakow (currently a part of the TEVA group) and Regulatory Intelligence Manager for the PLIVA Group. Before joining the generic medicines industry, she worked as a University researcher and lecturer at the Faculty of Pharmacy in Krakow (Poland) as head of Department of Pharmaceutical Law and Pharmacoeconomics. She is a qualified pharmacist.


Medicines for Europe

Caroline Kleinjan

Chair of the Regulatory and Scientific Affairs Committee Medicines for Europe, Sandoz

Nationality: Dutch
University Education:
1980-1986: University of Leiden Pharmacy, Graduated as pharmacist
1987: University of Utrecht Pharmacy, Graduated as public pharmacist Working experience: 1988-1990: Pharmacist in a public pharmacy
1990-1992: QA Manager, Multipharma B.V. (now rebranded into Sandoz B.V), the Netherlands Education as QP, acting as QP for Modipack (packaging company, owned by Ciba-Geigy B.V)
1993-1994: Regulatory Affairs Manager, Multipharma B.V. (now rebranded into Sandoz B.V.), NL
1995-2004: Subsequently Technical Affairs Associate, Registration Manager and Head of the Centre for Generic Drug Registration Europe, Novartis Generics
Since 01-01-2005 Head Regulatory Competence Centre Europe, Sandoz.
This department is responsible for all new submissions in geographical Europe within the Sandoz organization and subsequent maintenance of the marketing authorization till launch of the product. After launch the marketing authorization maintenance is moved to a dedicated maintenance team.


Medicines for Europe

Koen Laenen

Regulatory Affairs and Quality Manager, Medicines for Europe

Koen Laenen joined Medicines for Europe in November 2018 as Regulatory Affairs and Quality Manager. Prior to Medicines for Europe, Koen was Business Unit Director at Ardena NV leading a team of CMC writers and Regulatory Affairs Officers from 2015 till 2018. Prior to that Koen was working for +10 years for Jubilant Pharmaceuticals NV as Head of Operations. In this function he was overlooking the performance and deliveries of the R&D projects, Site Transfers and Bio-Equivalence Studies to ensure that the planned deliverables were executed on time. And to manage the Regulatory Affairs and Quality Assurance departments in Europe, to timely obtain and maintain all market. Koen has a university degree in biotechnology and prior to starting in the pharmaceutical business he worked for several years as researcher in molecular neurobiology at university of Ghent.


Medicines for Europe

Esther Martinez

Scientific Administrator Manufacturing Quality and Supply Chain Integrity, Committees and Inspections, EMA

Esther Martinez joined the European Medicines Agency in January 2011. She has since held various roles including co-ordination of GMP inspections and assessments of quality defects and product recalls.
Ms Martinez is currently part of the GMP/GDP Inspectors Working Group secretariat. In addition, she is the EMA business liaison for EudraGMDP and the interface between the European Commission and EMA with regard to the implementation of the EU Falsified Medicines Directive. Since August 2018, she is the co-chair of the working group on supply chain disruptions of the EMA/HMA Task Force on Availability of Authorised Medicines.
Esther obtained her degree in Chemistry from the University Autonomous of Madrid in Spain. She holds an Advanced Studies Diploma in Chemistry as a Multidisciplinary Science and a Postgraduate Certificate in Pharmaceutical Medicine (Drug Development Science) from King’s College London. In 2017, she completed her Qualified Person training at University College London.


Medicines for Europe

Laure Geslin

Head of Division Proper Use, FAMHP (Belgium)

Biography soon available.


Medicines for Europe

Valerie Jensen

Center for Drug Evaluation and Research (FDA)

CAPT Valerie Jensen is Associate Director of the Drug Shortage Staff at the U.S. Food and Drug Administration. She received a B.S. degree in Pharmacy from the University of Iowa in 1990. She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991. She worked as a clinical pharmacist for Indian Health Service hospitals in Arizona and New Mexico before joining FDA in 1999. She was one of the initial developers of FDA’s Drug Shortage Program and was named Associate Director in 2012.


Medicines for Europe

Giorgio Ricco

TEVA

Biography soon available.


Medicines for Europe

Geraldine Moore

Senior Registration Manager, Mylan

Geraldine Moore is a pharmacist by training and has over 17 years’ experience in Regulatory Affairs within the generics industry and is currently a Senior Registration Manager at Mylan. She is also a member of the Medicines for Europe Brexit Task Force and the Joint Life Science Industry Coalition on Brexit.


Medicines for Europe

Susanne Winterscheid

BfArM (DE)

Susanne is biologist and started at the BfArM in the variation section after a few years of employment in pharmaceutical industry. Since 2005 she was heading the Project Management of a licensing division at BfArM. Since 2008 she is Chair of the Joint CMD working party for variations and member of the EU Variation Task Force. In November 2011 she has become the German member of the CMDh. Since June 2015 she is Head of Licensing Division 3 at BfArM.


Medicines for Europe

Hélène Bruguera

EDQM

Mrs Hélène BRUGUERA graduated in Biochemistry from the University of Nancy, France and has a Master in Industrial Pharmacy from the University of Strasbourg, France. She worked for the pharmaceutical industry for 10 years in analytical development and in the preparation of the quality part for marketing applications. She joined the EDQM in year 2000, and is currently the Head of the Certification Department. She deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and APIs (ICH) and is currently co-chair of the IPRP Quality Working Group of Generics.


Medicines for Europe

Florian Schmidt

DG SANTE

Florian Schmidt is the deputy head of unit of the Commission's pharmaceutical unit B.5 in the Directorate-General for Health and Food Safety (DG SANTE). He is a lawyer by training and joined the Commission in 2004. Amongst other things, he was involved in the implementation of the new pharmacovigilance legislation and followed the paediatric regulation, as well as general legal matters and court cases.


Medicines for Europe

Astrid Krupp

Vice President Regulatory Affairs, Business Unit Generics and Complex Formulations ELAMA & Asia Pacific, Fresenius Kabi Deutschland GmbH

Astrid Krupp is currently heading one of the regulatory affairs departments of Fresenius Kabi and is in this position responsible for the definition of best regulatory strategies for development and registration of new products and maintenance of existing portfolio globally. Astrid Krupp holds a degree as state-certified food chemist from the TU Braunschweig, Germany. She started her career 1999 working in the regulatory affairs department of a small privately-owned company that soon underwent several mergers and finally became the leading generics affiliate of Sanofi in EU. She then joined Fresenius Kabi in 2007 to broaden her scope and work globally. Her focus is on regulatory strategies and CMC and since 2011 she is part of the Regulatory and Scientific Affairs Committee of Medicines for Europe.


Medicines for Europe

Sarah Faircliffe

Legal Director, Bird & Bird

Sarah is a Legal Director in Bird & Bird's London office. As a member of the firm's International Life Sciences Group, she specialises in European regulatory law concerning medicinal products, medical devices and related areas.
Sarah offers unique insight into the law and procedures concerning the regulation of medicines, having spent 10 years as Legal Adviser with the European Medicines Agency (EMA). During her time at the EMA, she advised on many areas, including orphan drugs, paediatrics and generics of centrally authorised products, as well as advising the EMA's scientific committees on legal issues.
She also played a key role ensuring that the new EU member states joining in 2004 brought their pharma legislation and procedures into line with EU requirements. Working closely with the European Commission, she assisted with a number of pieces of litigation and the drafting and implementation of various pieces of legislation.
Since joining Bird & Bird, Sarah has assisted a wide range of clients on all aspects of the regulation of products in the life sciences sector. This ranges from advising on the correct interpretation of legislation, guidelines and case law to helping to steer clients through procedures and negotiations relating to the marketing of their products, including representing them in discussions with regulatory bodies. Strategies and disputes concerning regulatory data protection and orphan exclusivity are a particular focus of her current work, with two ongoing cases in the EU General Court.
Sarah is a regular speaker at conferences and workshops and contributes to a number of publications. She is co-chair of Bird & Bird's Life Sciences Regulatory Group.


Medicines for Europe

Koosje van Lessen Kloeke

Leijnse Artz

Biography soon available.


Medicines for Europe

Sonia Ribeiro

EMA

Biography soon available.


Medicines for Europe

Susana Almeida, PhD

Clinical Development and Safety Director, Medicines for Europe

Dr. Susana Almeida is Quality and Clinical Development Director at Medicines for Europe (formerly EGA). Before joining Medicines for Europe, Susana was the Chair of the Bioequivalence Working Group for almost 15 years. She has worked in the clinical trials field in Europe and in North America, and her experience includes the pharmaceutical industry and clinical research organisations. She has overseen the conduction of dozens of clinical trials carried out in Europe, North and South America and Asia. At Medicines for Europe, Susana is responsible for the coordination of the Bioequivalence and Clinical Development Working Group, the Pharmacovigilance Working Group and Workstreams, and of the Medical Device Task Force She is a Topic Leader representing IGBA in the drafting committee of the International Council for Harmonisation (ICH)'s M09 topic. She holds a PhD in Clinical Pharmacology from the Faculty of Medicine, Universidad Autònoma de Barcelona (UAB), Spain and has authored several scientific papers in the field of clinical trials.


Medicines for Europe

Nivedita Valentine

Accord Healthcare

Biography soon available.


Medicines for Europe

Pavel Farkas

Senior Director Global Generics Clinical R&D, TEVA

Pavel Farkas graduated and earned a Doctor of Pharmacy degree from J.A. Comenius University and Institute of Experimental Endocrinology of Slovak Academy of Sciences in Bratislava, Slovakia, completed a specialization degree in Clinical Pharmacy at the National Institute of Oncology in Bratislava, Slovakia and Pharmaceutical Medicine at the Charles University in Prague, Czech Republic. He joined the generic pharmaceutical industry following a career in the field of basic pharmacological and endocrinological research and has been working in the area of clinical development of generic products for over 20 years. He joined PLIVA in 2004 with responsibilities and experience covering pharmacokinetic, bioequivalence and therapeutic equivalence studies for generic products, conducted mostly for EU/CEE, US and Canadian regulatory submissions as well as respective GCP and regulatory aspects. Pavel Farkas is currently responsible for PLIVA/TEVA’s R&D Biopharmaceutics operations, acting as a member of the Bioequivalence Working Group of Medicines for Europe and Steering Committee of AAPS Generic Pharmaceutical Focus Group.


Medicines for Europe

Augusto Filipe, Dr. MD

Head of the Medical Department and QQPV, EudraVigilance Representative, Tecnimede

  • Member of the Portuguese Medical Association.
  • Head of Medical Departmet of Farmoz/Grupo Tecnimede, Portugal.
  • European Union Qualified Person for Pharmacovigilance (EU QPPV).
  • Member of the Eudravigilance Expert Working Group (EV-EWG).
  • Member of Medicines for Europe - Pharmacovigilance and Safety Working Group (PhVWG).
  • Published severals scientific papers in peer review journals (areas of interest: clinical trials, pharmacovigilance and safety, respiratory diseases).

Medicines for Europe

Jan Welink

MEB (NL)

Biography soon available.


Medicines for Europe

Fakhredin Sayed Tabatabaei

MEB (NL)

Fakhredin Sayed Tabatabaei is a medical doctor and an epidemiologist. He works as a senior assessor at the pharmacovigilance department of the Dutch national agency (MEB) for almost 14 years, and has been involved in May processes regarding Patient Information documents. Since 2017, he is participating in the 'Better Use programme,' initiated within the Dutch agency, focusing on improving access to product information, so that both patients and healthcare providers can search for, find, consult and use information about medicines.


Medicines for Europe

Anjana Pindoria

Extedo

+ 15 years of experience in Regulatory Affairs and special programmes, ranging from writing MAA applications, Implementation of eCTD; XEVMPD, and multiple company integration of global product acquisitions.
• Proactive Member of the SPOR Substance Subgroup and the ISO IDMP Taskforce.
• Co-chair of the IAFT ePI Working group
• Member of the Medicine for EU Digital Taskforce.
In 2016 Anjana started working within EXTEDO's Product Management Team. Her role enables her to listen to the industry pains as well as scanning the horizon for future changes that could impact the way we work today.


Medicines for Europe

Juan García-Burgos

Head of Public Engagement Department, European Medicines Agency (EMA)

Juan Garcia Burgos is a Qualified Medical Doctor from the University of Autonoma in Madrid, specialised in urology. Juan worked as an urologist surgeon at the hospital Gregorio Maranon in Madrid. He joined the European Medicines Agency in 2002 in the scientific Units and was responsible for coordinating the preparation of EU clinical guidelines for drug development. He took up new responsibilities in 2005 where he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and HealthCare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences.
In January 2017, he was appointed Head of Public Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.


Medicines for Europe

Georg Neuwirther

Head of IT, Austrian Medicines and Medical Devices Agency (AGES MEA)

Georg Neuwirther joined the Austrian Agency of Health and Food Safety in 2003. He was responsible for real estate management before holding different management positions in IT. In 2014 he was appointed Head of IT of the division “Austrian Medicines and Medical Devices Agency (AGES MEA)” after the successful migration of the legacy drug information system to a new business solution. Georg Neuwirther is board member of the EU Telematics Management Board (EUTMB) and member of several telematics groups (e.g. ITDEC, TEAB, EUNDB, SPOR TF). As chair of the Electronic Application Form (eAF) Maintenance Group he is also leading the project CESSP Phase 1. In 2019, his IT and business expertise also contributed to the development of the draft roadmap for the introduction of the electronic product information (ePI).


Medicines for Europe

Peter Bachmann

Head 'International Liason Office and Conferences', Executive Department ‘European Union and International Affairs’, Federal Institute for Drugs and Medical Devices (BfArM), DE

Peter Bachmann has joint in 1999 the Federal Institute for Drugs and Medical Devices (BfArM, Germany), Department of ‘Drug Approval’. He was in the following years the head of several subunits and units responsible for the variation and authorisation of medicinal product in the framework of MRP, including the task of the German representative to the MRFG (Mutual Recognition Facilitation Group). Following the reorganisation of the BfArM in July 2005, Peter Bachmann was appointed as Senior Expert for ‘European Drug Regulatory Affairs’ at Department ‘European and International Affairs’. He was the appointed German CMDh member until November 2011 and served as elected CMDh Chair from November 2011 till November 2017. His current position is the Head of ‘International Liason Office and Conferences at BfArM, the German Member of the NtA, a member of the EUNDB and the SPOR Task Force, ), a member of the HMA WG ‘Better Use of Medicines’ (incl the ePI Task Force), a member of the International Pharmaceutical Regulators Programme (IPRP) Management Committee (since 2018), the European Lead of the ICH GDG (Generic Discussion Group) and member of different other European and International AdHoc Working Parties.. His is a lecturer for „Drug Regulatory Affairs‟ at several Universities (Bonn, Duisburg, Basel, Copenhagen), a Honorary Member of the Middle-European Society for Regulatory Affairs (MEGRA), a Honorary Lifetime Member of TOPRA, a former member and Vice-Chair of the DIA Advisory Committee Europe (2007 – 2013), DIA Board of Directors (2013 – 2016) and is currently serving at the DIA Council of Regulators and the TOPRA Advisory Committee.


Medicines for Europe

Kevin Airey

Director Regulatory Affairs EMEA Affiliates, Mylan

Kevin started his career in R&D specialising in Generic OSD formulations at Adcock Ingram Laboratories in South Africa. Subsequently and for 13 years, he worked as an affiliate in New Zealand for a subsidiary of Merck Generics and managed the regulatory and PV responsibilities for both the generic arm of the company and their agency companies, Alcon Laboratories, Galderma and Ferring AB, all of whom marketed their products in NZ through Merck Generics. In 2000, he moved back to the UK to learn about European regulatory submissions on a 18 months secondment and then accepted a permanent position with the Merck Generics regulatory management team in 2003. Kevin has also been an active participant of a couple of industry working groups over subsequent years. He was on the 'Centralised Procedure' working group within Medicines for Europe (EGA) who's role it was, to work with EMA to introduce the Centralised Procedure to the generic industry. Currently he's part of the 'ebooklet' working group within Medicines for Europe. Merck Generics was sold to Mylan in October 2007. In 2010 Kevin was seconded to Mylan Seiyaku, Tokyo Japan for almost 2 years, to mentor the newly appointed Regulatory and Pharmacovigilance Director before returning to the UK, to establish the 'Affiliate Support Team' for Mylan's Regulatory affiliates across the European region which is his current position.


Medicines for Europe

Britt Vermeij

TEVA

Britt graduated as Pharm.D. at the University of Utrecht. In 2001, she started working for Teva in the Regulatory Affairs Department of the Dutch commercial Business Unit. From 2005 she headed this department in Teva Netherlands. In 2009 she got the position of Regional RA Head, in which she was managing Western European Market RA departments in 11 countries. From 2012 on she changed to the role of European Regulatory Intelligence and Policy, which changed in April 2018 to her current role of Director Regulatory Affairs Projects and Policy implementation in which she is the EU RA project lead for implementation of EU projects like Brexit and FMD, participates in association projects like ePI and Variations, is doing assessment of new, revised or proposed legislation and providing EU Regulatory information throughout the company.


Medicines for Europe

Katarina Nedog

Head Business Process & Excellence Information Management & Systems, Global Regulatory Affairs, Sandoz

Katarina Nedog is Head Business Process & Excellence Information Management & Systems, global Regulatory Affairs at Sandoz since September 2018. In this role, she leads the functions responsible for creation and harmonization of IM&S business processes, IT system related training coordination and execution, submission resource planning and the teams responsible for central document processing.
Prior to Sandoz, Katarina worked for nearly 4 years at the Medicines for Europe - Brussels based trade association representing generic, biosimilar and value added pharmaceutical industries. Within the Regulatory and Scientific team, she coordinated the work of relevant working groups, represented the association and led multiple projects, covering pharmacovigilance, telematics, antimicrobial resistance and environment-related topics.
Katarina developed her passion for regulatory affairs during her position as Regulatory Affairs Manager at Sandoz between 2007 – 2013. Working in a dynamic, international working environment, she always strived to accomplish the most in a smartest way.
Katarina holds a bachelor’s degree in Pharmacy from University of Ljubljana, Slovenia.


Medicines for Europe

Stephanie Kohl

Policy & Advocacy Officer, European Association of Hospital Pharmacist (EAHP)

Stephanie Kohl is the Policy & Advocacy Officer of the European Association of Hospital Pharmacist (EAHP) which represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. In her capacity as Policy & Advocacy Officer, Stephanie coordinates and supports EAHP’s engagement in policy discussions relevant to hospital pharmacists.


Medicines for Europe

Lei Zhang, Ph.D.

Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Lei Zhang, Ph.D., serves as the Deputy Director of the Office of Research and Standards (ORS), Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. Dr. Zhang was previously Senior Advisor for Regulatory Programs and Policy in the Office of Clinical Pharmacology at CDER, FDA. She is an accomplished professional with more than 21 years of combined experiences in the areas of drug research, development and regulatory review and approval. She has contributed to numerous guidance development and research projects focused on the science-based regulatory decision-making. Before joining FDA in 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, Schools of Pharmacy and Medicine. She has authored and co-authored numerous papers, book chapters, abstracts, and invited presentations in the area of clinical pharmacology and regulatory science. Dr. Zhang received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is currently a Board member of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) and serves on the Clinical Pharmacology and Therapeutics Editorial Board. She is a member of the ICH Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Leader. Dr. Zhang was named American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013.


Medicines for Europe

Luther Gwaza

WHO

Biography soon available.


Medicines for Europe

Remco Munnik

Associate Director, Iperion Life Sciences Consulting

+20 years in experience in Life Science and Regulatory Affairs, 10+ years consultancy with focus on Regulatory Information Management (RIM) and electronic submissions.
- Strategy & Project manager
- Subject Matter Expert for Regulatory Information Management systems (RIM), eCTD, xEVMPD and ISO IDMP
- Member of EMA ISO IDMP Task Force Organizations and Products
- Chair Medicines for Europe Telematics group (eAF, eCTD, CESP, xEVMPD and ISO IDMP)


Medicines for Europe

Isabel Chicharo

Head of Data and Information Lifecycle Management Service Deputy Programme Manager for the SPOR/IDMP Programme, EMA

Isabel is responsible for the implementation and management of a Master Data Management Service which will be used to manage Substances, Products, Organisations and Referential data (also known as SPOR). She coordinates operational aspects of the service as well as business aspects of the programme and reports directly to Francisco Penaranda the Head of Business Data and Analytics Department.
Isabel has a Pharmacy degree, a post graduate degree in Pharmaceutical regulation and 17 years of data management experience in the field of Medicines. Her experience has covered Software companies, a National Regulatory Authority as well as EMA. She has coordinated complex projects and teams on various EMA internal and international projects.
Specialties: Good knowledge of European pharmaceutical legislation and procedures.
Experience in information and data management, data quality assessment and control.


Medicines for Europe

Joris Kampmeijer

MEB (NL)

Biography soon available.


Medicines for Europe

Stuart Izod

Head Regulatory Information Management, Global Regulatory Affairs, Teva

Stuart and his team are responsible for Teva’s centralised registration data management and XEVMPD submissions operations. Also responsible for executing the global change programmes required to successfully implement the data management systems and processes required to comply with regulatory data standards and submission requirements (e.g. ISO IDMP) as they evolve globally.
Stuart has worked within Pharmaceutical R&D for more than 20 years, focussed mainly within big pharma Clinical and RA. This included leading the successful implementation of a foundational master data management solution as part of a major global change programme.


Medicines for Europe

Laura Oliveira Santamaria

Chair of the CMDh, AEMPS (ES)

Biography soon available.


Medicines for Europe

Kora Doorduyn-van der Stoep

Vice-Chairperson CMDh, NL-CMDh member/Senior Policy Adviser Medicines Evaluation Board (MEB) (NL)

She works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/ Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).


Medicines for Europe

Jitka Vokrouhlická

SUKL (CZ)

Jitka Vokrouhlická graduated at the First Faculty of Medicine, Charles University, Prague. After graduation she worked as a clinical researcher in the Centre for Metabolic Bone Diseases in the General Teaching Hospital in Prague until joining the State Institute for Drug Control in 2008. From 2008 till 2010 Jitka Vokrouhlická worked as a Clinical Assessor and a Coordinator of European procedures in the State Institute For Drug Control, from October 2010 till December 2014 as the Head of Department of Marketing Authorisation Agenda and in January 2015 she was appointed the Head of Coordination and Regulation Department of the Marketing Authorisation Section at the State Institute For Drug Control. Jitka Vokrouhlická has been the Czech CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – human) member since January 2010.


Medicines for Europe

Ana López de la Rica Manjavacas

CMDh Member for Spain, AEMPS (ES)

Ana López de la Rica is the CMDh member representing the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain, where she currently coordinates regulatory affairs and standardisation tasks and started to work in 2008 performing Clinical assessesment. She is member of the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations serving the INN Expert Group and NCA Regulatory Liason (Alternate) representing AEMPS of the ISO-IDMP SPOR project coordinating by EMA. Before joining the AEMPS, Ana López de la Rica worked as Head of Regulatory Affairs in Noscira S.A. (Zeltia group) and before of that as a Regulatory Affairs Specialist in Lilly S.A. (Spain) from 2003 to 2008. After getting her Bachelor of Pharmacy in the Facultad de Farmacia, Universidad de Valencia (Spain) from 1996 to 2001, she has completed her education by performing a Master in Development, registration and regulation of medicines in the Universidad Autónoma de Barcelona (Spain) from 2002 to 2003 and a twoyear Master in Health Economics and Pharmacoeconomics in the Universitat Pompeu Fabra, Barcelona (Spain) from 2012 to 2014.


Medicines for Europe

Sabina Uzeirbegović

HALMED (HR)

Sabina joined Croatian Agency for Medicinal Products and Medical Devices (HALMED) in 2006, where she currently holds position of Principal Coordinator for Mutual Recognition and Decentralised procedures (MRP/DCP). Her main responsibilities include coordination and overseeing of regulatory procedures within the MRP/DCP in HALMED. She has been Croatian representative to Coordination group for Mutual Recognition and Decentralised procedures – human (CMDh) since the accession of Croatia to the EU, as well as representative to the NtA. She is also a member of several WG within the CMDh. She is a pharmacist with postgraduate specialty study in clinical pharmacy.