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.
Sabine Straus
Dutch Representative of the PRAC, Chair, Medicines Evaluation Board
Dr. Sabine Straus has been with the Medicines Evaluation Board in the Netherlands since 1997, where she started as an assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry. For here thesis she researched medicines, Qtc prolongation and sudden cardiac death at the Erasmus Medical Center in Rotterdam in combination with work at the MEB (PhD degree 2005 “Drugs, QTc prolongation and Sudden Cardiac Death”). She completed her Master of Science in Clinical Epidemiology in 2002. She has been head of the department for Pharmacovigilance at the MEB from December 2005 until July 2012.
Since 2012 she has been the Dutch delegate in the Pharmacovigilance Risk Assessment Committee (PRAC) and in July 2018 was elected to chair the PRAC in July 2018.
In addition she holds a part time a position as associate professor at the department of Medical Informatics, Erasmus Medical Center, Rotterdam. She published amongst others on sudden cardiac death, risk management and additional risk minimisation, biologicals, signal management and has been involved in several PhD projects, European research projects and drafting of regulatory guidance.
Dr. med. Sebastian Horn
Head Patient Safety, Sandoz International and Chair PV Working Group, Medicines for Europe
Sebastian is Head Patient Safety at Sandoz / Novartis Generics, overseeing Patient Safety globally for all Sandoz Generics and Medical Devices since Oct 2010. As a physician specialized in Legal Medicine, his prior experience includes being QPPV and Global Head Central Safety Operations & Safety Affiliates at Roche, CSO at Fresenius Kabi, and Senior Medical Advisor at Boehringer Ingelheim Corporate Safety, where he also was member of the CIOMS VIII initiative on Signal Detection, and chair of the German Drug Safety Master Class.
Kaisa Immonen
Director of Policy, European Patients' Forum (EPF)
Kaisa Immonen (MA) is Director of Policy at the European Patients’ Forum (EPF). She has a Master’s degree in International Relations (UK and Finland). She is responsible for the overall lead of EPF’s policy and advocacy work at EU level, strategic planning, policy analysis, and building positive relationships with EU institutions, international organisations such as the OECD, WHO and stakeholders. She leads EPF’s work on patient empowerment and involvement, patient safety and quality of care, and health literacy.
She is currently co-chair of the European Medicines Agency’s Patients and Consumers Working Party since 2016. She represents EPF on the OECD’s health care quality and outcomes working party, the OECD PaRIS Task Force and the CIOMS working group XI on patient involvement. She is also a member of the BMJ Patient Panel and the ICHOM working group on general adult health core outcomes set in her personal capacity.
Before joining EPF in 2010 she worked in EU health policy, advocacy and external communications roles in both the private and non-profit sectors.
Dr. Shanti Pal
Group Lead, Medicines Safety, WHO
Education: B. Pharmacy (Hons), M. Pharmacy and PhD in Pharmacology
Current Job Title: Team Lead (a.i), Pharmacovigilance, WHO, Switzerland
Key Responsibilities in WHO:
• Leading and managing WHO Pharmacovigilance
• Building partnerships with public health programmes and Global Health Initiatives such as the Bill and Melinda Gates Foundation, Global Fund
• Mobilising resources for pharmacovigilance in Low- and Middle-Income Countries (LMIC)
Key Positions of relevance:
• Secretary to Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring
• Secretary to the WHO Advisory Committee on Safety of Medicinal Products
• Deputy Member, Uppsala Monitoring Centre (UMC) Board
• WHO Nominee, ICH E19 working group
• WHO Designated Technical Officer, CIOMS
Key achievements:
• Developed the WHO pharmacovigilance strategy for resource-limited settings.
• Key driver in developing additional methods such as Cohort Event Monitoring and Targeted Surveillance to complement spontaneous reporting systems
• WHO Technical lead for convergence of pharmacovigilance efforts in Regional Economic Communities (REC) in Africa and ASEAN
Selected Publications
• S Pal, S Olsson, E Brown. The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project, Drug Safety, April 2015
• H Ndagije, V Nambasa, S Pal et al. Targeted Spontaneous Reporting of Suspected Renal Toxicity in Patients Undergoing Highly Active Anti-Retroviral Therapy in Two Public Health Facilities in Uganda. Drug Safety, March 2015
• S Pal, C Duncombe, D Falzon, S Olsson. WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems. Drug Safety, 2013
• S Xueref, J Daviaud, S Pal. The Global Fund and pharmacovigilance systems in resource-limited settings. Lancet, 2013
Martin Huber
PRAC Vice Chair, BfArM
Dr Martin Huber is the German member of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Since October 2018 he is also the vice-chair of the PRAC. In addition, he is also the chair of the Non-prescription medicinal products Task Force of the CMDh since May 2017. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he has been head of the unit 'PRAC and other Committees', and since 2017 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors' within BfArM's division of pharmacovigilance.
Uwe Gudat
Head of Clinical Safety & Pharmacovigilance Biosimilars, Fresenius Kabi SwissBioSim GmbH
Uwe Gudat received his medical degree from the Philipps-University of Marburg, Germany. He is licensed in internal medicine specializing in metabolic disorders, training under Michael Berger in Düsseldorf Germany. Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. He has led global clinical development teams, acted as global medical brand director, led global clinical due diligence teams for in-licensing, guided oversight over clinical trial designs, product safety assessments and first in man transitions. Currently he serves as Head of Clinical Safety & Pharmacovigilance at Fresenius-Kabi SwissBioSim.
Peter Arlett
Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)
Education:
• Qualified in Medicine from University College London (UCL)(1991)
• Member of the Royal College of Physicians (MRCP) of London (1994)
• Member of the Faculty of Pharmaceutical Medicine (MFPM) of the Royal College of Physicians of London (2002)
• Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London (2007)
• Managing Successful Programmes (MSP) Practitioner (2014)
Career to date:
• Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (August 2013 – present)
• Head of Pharmacovigilance and Risk Management Sector, European Medicines Agency (2008-2013)
• Principal Administrator, Pharmaceuticals Unit, DG Enterprise and Industry, European Commission (2003-2008)
• UK delegate to the European Committee for Human Medicinal Products (CHMP) (2001-2003)
• Specialist Assessor and Manager, Medicines Control Agency (now MHRA) (1996-2001)
• Hospital Physician, UK NHS, UCL, Oxford, Hammersmith (to 1996)
Sophie Radicke
GPvP Inspector, MRHA
Sophie joined the GPvP inspectorate at the MHRA as an inspector in January 2018. She previously worked as a scientific assessor responsible for the assessment of safety variations in the Vigilance and Risk Management of Medicines (VRMM) division at the MHRA for just under two years. Prior to joining the Agency, Sophie worked in medical information for a service provider where she also supported quality assurance activities and the accreditation of new staff. Sophie started her career in the pharmaceutical sector when she worked on a regulatory affairs project for a mid-sized pharmaceutical company in Germany. Sophie has an MSc in Forensic Anthropology and a degree in Human Biology during which she specialised in pharmacology.
Fakhredin Sayed Tabatabaei, MD, PhD
Project Manager ePI (electronic Product Information), MEB
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 13 years, and has been involved in many processes regarding Patient Information documents. Since 2017, he is part of 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."
Andrew Donaldson
European Head of PV Technology Services, IQVIA
Andrew is European Head of PV Technology Services for IQVIA . Andrew was a Partner at Foresight Group, a specialist PV Technology company, before it was acquired by IQVIA in 2017. Andrew has been consulting within the domain of Pharmacovigilance for 18 years, during this time, he has engaged in paid PV consulting assignments in more than 30 different pharmaceutical companies.
Andreas Iwanowitsch
Head Global Pharmacovigilance Unit, STADA Arzneimittel AG
Andreas has a PhD in Chemistry and works in the pharmaceutical industry since 1996 in the fields clinical research, biostatistics and pharmacovigilance. In 2008 he joined STADA and became Head of Global Pharmacovigilance Unit and EU QPPV Backup in 2013.
Georgy Genov
Head of Signal and Incident Management, Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)
The Department provides leadership and coordination across the pharmacovigilance activities of the Agency, including coordinating the EMA pharmacovigilance matrix and the EU-level activities across the Member States. It coordinates the EU medicines regulatory network incident management plan, including the incident review network, urgent and non-urgent safety information exchange processes, as well as withdrawn products. It is responsible for detecting and managing new safety issues and it manages queries and provides information on ADRs from EudraVigilance. It oversees the development of IT systems for pharmacovigilance, as well as the development of new methods to improve the effectiveness of pharmacovigilance (including measuring the impact of pharmacovigilance). The Department also sets standards and guidance for pharmacovigilance and coordinates epidemiology and big data across the EMA, including delivering data and evidence using epidemiological methods to the committees Dr Georgy Genov is qualified as medical practitioner. He joined the pharmaceutical industry in 1998. Since then he has gained experience in Drug Development, Medical Affairs and Pharmacovigilance. In 2010, he joined the Pharmacovigilance and Risk Management team of the European Medicines Agency. In 2011 Dr Genov was appointed as Head of Signal Management service within the Pharmacovigilance Department and in 2017 he fulfilled also the function of acting Head of Pharmacovigilance and Epidemiology Department for a year.
Kora Doorduyn-van der Stoep
Vice-Chairperson CMDh (NL) and CMDh Member/Senior Policy Adviser, Medicines Evaluation Board (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).
Klaudija Marijanović Barać
Senior Director, Teva Periodic reports & risk management Centre (TPC), Teva Pharmaceuticals
Klaudija Marijanovic Barac is a physician with more than 17 years of experience in different aspects of pharmacovigilance and different therapeutic areas. She started working in pharmaceutical industry in 2002, being one of the founders of Pharmacovigilance Department in PLIVA. She was Lead Safety Physician in Barr Group and established RMP Group in Teva in 2015. She also led project of development of additional risk minimization implementation tracking tool in Teva.
At present she is Senior Director within TPC. Her team is supporting marketing authorizations in the EU and international markets for generic, innovative and biological/biosimilar products.
Klaudija is member of the Pharmacovigilance workstream within Medicines for Europe.
Benedicte Lunddahl
Head of Pharmacovigilance Section, Danish Medicines Agency (DK)
Benedicte Lunddahl holds the position as Head of European Pharmacovigilance at the Danish Medicines Agency (DKMA) since 2016. The unit covers assessment of PSURs, RMPs, PASS, signal detection and signal management on European data, handling of DHPCs etc.
She joined DKMA in 2005 and has been working in the field of pharmacovigilance since then. From 2013 to 2016 she headed the ICSR handling team, and prior to that she worked with different disciplines of pharmacovigilance activities, including supporting the Danish PRAC members in PRAC (previously Pharmacovigilance Working Party) meetings. Benedicte has gained a broad knowledge of the European pharmacovigilance legislation and EMA procedures as well as the national Danish pharmacovigilance system.
Paul Fleming
Technical Director, British Generic Manufacturers Association
Paul Fleming is Technical Director of the British Generic Manufacturers Association (BGMA) and the British Biosimilars Association (BBA). The roles include close and regular working with MHRA, Department of Health and Social Care, the NHS, UK Government and other stakeholders. At a European level, Paul is a member of the regulatory and quality committees of Medicines for Europe. In 2015 he wrote the Regulatory Efficiency Report for EGA, setting out a wide range of recommendations identifying opportunities for improvement within the regulatory system for generic medicines. Paul has 15 years’ experience from working in the generic sector of the European pharmaceutical industry, in a variety of senior board level roles covering R&D, drug regulation, pharmacovigilance and clinical development. Earlier in his career Paul spent six years with the MHRA as a pharmaceutical assessor. He is a registered pharmacist and holds a higher degree in pharmaceutical technology. Throughout his professional life Paul has maintained an involvement with the science of pharmaceutical development connecting to how medicines can be used for the maximum benefit of patients and the NHS.
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.
