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Hotel Grand Majestic Plaza

Jun 15, 2017 8:15 AM - Jun 16, 2017 5:00 PM

Truhlarska 16, 110 00 Prague 1, Czech Republic

DIA Workshop on Benefit-Risk Strategy


Martin  Huber, MPH, MPharm

Martin Huber, MPH, MPharm

Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Dr Martin Huber is the Vice Chair 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. 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 is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.

Steve  Mayall, PhD

Steve Mayall, PhD

Director, Huron Consulting Group, United Kingdom

Steve Mayall is a Principal Consultant in Huron’s Life Sciences Practice (formerly known as Pope Woodhead). He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management for more than 15 years. Key areas have included developing risk management plans; designing, implementing and evaluating risk minimisation and pharmacovigilance activities; and performing structured benefit-risk assessments.

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, Ivigee, Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Steffen  Thirstrup, MD, PhD

Steffen Thirstrup, MD, PhD

Chief Medical Officer, European Medicines Agency, Netherlands

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

Martin  Votava, MD, PhD

Martin Votava, MD, PhD

Chief Medical Officer , PrimeVigilance, Czech Republic

Martin is an expert in pharmacology and regulatory science. He represented the Czech Republic in The Committee for Medicinal Products for Human Use at EMA (2007-2010), while working as the Head of the Preclinical and Clinical Documentation Assessment Unit at the State Institute for Drug Control. He coordinated and provided assessment for centralized marketing authorization procedures and referrals as a rapporteur or a co-rapporteur for new active substances, biosimilar and generic medicinal products. He gained his education in pharmacology at Charles University in Prague (MD, PhD, Prof. Assoc.), where he held the position as Head of the Pharmacology Department at the 2nd Faculty of Medicine.

Kaatje  Bollaerts, PhD

Kaatje Bollaerts, PhD

Senior Statistician, P-95, Belgium

Kaat Bollaerts is a methodologist/statistician with a passion for epidemiology. She obtained her master in theoretical psychology at Leuven University (Belgium) in 2001, a master in statistics in 2004 and a PhD in statistics in 2009, both from Hasselt University (Belgium). After obtaining her PhD, she started working as a senior scientist at Public Health, Belgium. In 2013, Kaat joined P95 to work on the ADVANCE project on Accelerated development of vaccine benefit-risk collaboration in Europe. Throughout her professional career, she was involved in consulting activities for private industry, governments and (inter)national public health institutions.

Emil Andrei  Cochino, MD, MHS

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands

Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

William  Gregory, PhD

William Gregory, PhD

Senior Director, Safety and Risk Management, Pfizer Inc, United States

He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.

Kimberley  Hockley, PhD, MPH

Kimberley Hockley, PhD, MPH

Global Benefit-Risk Management Scientist, Amgen, United Kingdom

Kimberley is a Benefit-Risk Management Scientist at Amgen. She provides expertise and guidance for global benefit-risk management and assists with structured benefit-risk assessments, risk management plans, additional risk minimization measures and methods to incorporate the patient perspective. Previously, she lead the Patient and Public Involvement team in PROTECT Benefit-Risk. She was a Research Associate at Imperial College London and completed her Masters and PhD in Public Health at the same institution; her work focused on how patients and the public can be meaningfully involved in the benefit-risk assessment of medicines.

Shahrul  Mt-Isa, PhD

Shahrul Mt-Isa, PhD

Associate Principal Scientist, HTA Statistics, BARDS Europe, MSD, United Kingdom

Dr Shahrul Mt-Isa is a senior statistician at the School of Public Health, Imperial College London. He has a width of experience and interest in benefit-risk assessment, decision analysis, evidence synthesis and data visualisation, as applied in pharmaco/-epidemiology & clinical trials. He works on PROTECT Benefit-Risk project for the past 5 years. He co-led the BR assessment methodology, visual representation reviews, BR training and website development (

Francesco  Pignatti, MD

Francesco Pignatti, MD

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

Bill  Richardson, MD

Bill Richardson, MD

Medical Advisor, NDA Regulatory Science Ltd, United Kingdom

Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He took up his first post in the pharmaceutical industry as a Medical Adviser in 1987. The next 15 years were spent in the industry in Medical Affairs, Clinical Development, and Pharmacovigilance. He joined the Medicines Control Agency (now MHRA) in 2002 and had responsibility for monitoring the safety of “black triangle” products; signal generation and assessment; pharmacovigilance assessment for CHM, PRAC and CHMP; assessment of licence variations; assessment of Periodic Safety Update Reports and Risk Management Plans; and assessment of advertising. He left the MHRA in 2014 to become a pharmacovigilance consultant for NDA Group.

Priya   Singhal, MD, MPH

Priya Singhal, MD, MPH

Senior Vice President and Global Head of Safety and Benefit Risk Management, Biogen, United States

Priya Singhal is the Global Head of Safety and Benefit Risk Management (SABR) at Biogen since 2013. She led the benefit-risk strategy for the filings of Plegridy, Alprolix, Eloctate, Zinbryta, Spinraza and oversees benefit-risk strategy for the investigational and marketed portfolio. Priya was at Vertex Pharmaceuticals from 2008-2012 in roles of increasing seniority in Global Safety and was VP, Medical Affairs from 2011-2012. From 2005-2008, Priya led benefit-risk for several compounds at Millennium Pharmaceuticals. She is an Internist with a MPH from Harvard School of Public Health. She is an invited speaker at Academic and Industry Forums and a recipient of several awards including the Healthcare Business Woman Rising Star award in 2012.

Álmath  Spooner, PhD

Álmath Spooner, PhD

Head of Europe Regulatory Policy & Intelligence (RPI), AbbVie, Ireland

Álmath is Head of Europe Regulatory Policy at AbbVie. Álmath dually qualified as a pharmacist and a barrister-at-law with a PhD from Trinity College Dublin and postgraduate qualifications in statistics and pharmaceutical medicine. Álmath has extensive experience in regulation and policy having held management and assessment roles at the Irish HPRA (2007-2019) and at EMA's PRAC (Vice Chair 2012-2018). Álmath was called to the Bar of Ireland in 2018 and practiced in Commercial Law prior to joining AbbVie in 2020. At EFPIA, Álmath chairs the Integrated Evidence Generation Working Group. She has prior experience in various global initiatives including at ICH. She is a member of the DIA Regional Advisory Council.

Vera  Tóth, MD

Vera Tóth, MD

Medical Expert, Gedeon Richter Plc., Hungary

Having my medical doctor certificate in 2001, I have started working as emergency doctor at the National Ambulance Service, Hungary. Quick decision making, practical approach and solution-based orientation proved to be very useful skills even in my later life at pharmaceutical industry, which I have started in 2010. I had the opportunity to spend some time as a medical writer; I have gained useful experiences regarding regulatory requirements. I am currently leading the department of medical strategy and coordination, having many types of challenges during my job that allow me to get an insight to all the main points of pharmacologic development.

Zuzana  Vinterova, PhD

Zuzana Vinterova, PhD

Strategic Advisor, Medical Writing, PrimeVigilance s.r.o., Czech Republic

Zuzana Vinterova received her PhD in Biochemistry from Charles University in Prague and she worked as a researcher at the Institute of Organic Chemistry and Biochemistry within the Czech Academy of Sciences, focusing on the major virulence factors of pathogenic yeasts (Candida spp.). Zuzana has joined PharmInvent (rebranded to PrimeVigilance in 2018) as a scientific specialist and medical writer and has now over 10 years of experience in medical writing of pharmacovigilance (PSUR/PBRER, DSUR, ACO, RMP) as well as regulatory science documents, needed throughout the full life-cycle of medicinal products.

Lesley  Wise, PhD, MSc

Lesley Wise, PhD, MSc

Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom

Lesley Wise has over 20 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues to ensure a companywide approach to Benefit - Risk Management and to maintain compliance with regulatory requirements. Lesley has been working as an independent consultant to the pharmaceutical industry for the last seven years and has liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.

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