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European Medicines Agency

Sep 08, 2026 8:30 AM - Sep 08, 2026 5:00 PM

Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands

EMA Risk Management Information Day

This in-person information day will provide an overview of key developments in EU pharmacovigilance guidance related to the safe use of medicines during pregnancy and breastfeeding as well as updates in GVP Module V Risk Management Plans and GVP Module VIII Post authorisation safety studies (PASS).

Faculty

Priya  Bahri, PHD

Priya Bahri, PHD

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and engagement for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research".

Georgy  Genov, MD

Georgy Genov, MD

Head of Pharmacovigilance Office, European Medicines Agency, Netherlands

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Viola  Macolic Sarinic, DRSC, MD, MSC

Viola Macolic Sarinic, DRSC, MD, MSC

Scientific Officer, European Medicines Agency, Netherlands

Dr. Viola Macolic Sarinic, MD, PhD, is a clinical pharmacologist with 20+ years in pharmacology, regulatory affairs, and pharmacovigilance. She held key roles at HALMED, EMA, and WHO, contributing to medicine safety. Currently, she is PRAC Scientific Lead at EMA, shaping pharmacovigilance in the EU and beyond.

Robert  Massouh, MPHARM, RPH

Robert Massouh, MPHARM, RPH

Head of Safety (PV) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom

Rob Massouh, is the Head of Safety (PV) Risk Management and Benefit-Risk Evaluation at GSK. In this role, he serves as the subject matter expert in risk management strategy and benefit-risk evaluation. Rob was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Rob is a registered Pharmacist and received his MPharm at the University of Manchester.

Ulla  Wändel Liminga, DrMed, MS, RPH

Ulla Wändel Liminga, DrMed, MS, RPH

Scientific Director Pharmacology/Toxicology, Medical Products Agency (MPA), Sweden

Ulla Wändel Liminga is a pharmacist, who has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Swedish Medical Products Agency. She has since then worked with non-clinical and clinical efficacy and safety assessments, and pharmacovigilance. In 2007, she became Scientific Director of Pharmacology and Toxicology. From March 2020, her position changed to Scientific Director Pharmacovigilance. From July 2012, she has also been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (EMA). In July 2024, she was elected chair person for the PRAC, and  started her mandate in the beginning of September 2024.

Eva  Jirsova, DrMed

Eva Jirsova, DrMed

Pharmacovigilance Assesor, State Institute For Drug Control, Czech Republic

Head of Pharmacovigilance dpt, State Institute For Drug Control, Czech Republic, and PRAC Member. Graduated in Medicine from Charles University, Prague (1984). Trained as a paediatrician (1985–1997), with periods of maternity leave caring for four children. Worked as a Clinical Pharmacologist from 1997 to 2004, since 2004 has been with the Pharmacovigilance Unit at the State Institute for Drug Control and since 2013 as Head of Pharmacovigilance dpt. Participant in EMA Pharmacovigilance Working Party, since 2012 PRAC Alternate and since 2017 PRAC Member. Has had a longstanding interest in the safety of medicines during breastfeeding since 1999 and has authored 10 publications in this field.

Anna  Beckmeyer-Borowko

Anna Beckmeyer-Borowko

Associate Director Epidemiologist, Novartis Pharma, Switzerland

Pharmacovigilance leader with extensive experience in pharma and a strong academic background, specializing in pregnancy safety, risk minimization and real-world evidence generation. Anna leads the Pregnancy Intensive Monitoring Initiative (PRIM) and its governance board across five marketed products, overseeing strategy, process optimization, data quality, follow-up, training, and governance standards. Her work also includes advancing innovative IT and AI-enabled solutions for data collection and analysis, while fostering collaboration across pharmaceutical companies.

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.

Liana  Martirosyan

Liana Martirosyan

PRAC Member and PRAC Vice-Chair, Medicines Evaluation Board (MEB), Netherlands

Dr Liana Martirosyan is a medical doctor with an MPH and a PhD in pharmacoepidemiology. She represents the Netherlands at the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and serves as its Vice-Chair. Liana joined the Medicines Evaluation Board (MEB) in 2012, where she worked as a pharmacovigilance assessor before becoming a PRAC member. Her special interests include interventions in clinical practice to minimise drug safety risks and the evaluation of the effectiveness of additional risk minimisation measures.

Marleen  van Gelder

Marleen van Gelder

Assistant Professor in PharmacoEpidemiology, Radboud University Medical Center, Netherlands

Cosimo  Zaccaria

Cosimo Zaccaria

Senior PhV specialist, European Medicines Agency, Netherlands

Cosimo Zaccaria is a signal management lead at the European Medicines Agency (EMA). Since 2022 he has been co-chair of the Signal Management and Review Technical (SMART) Working Group which is responsible for leveraging expertise in the field of signal detection by reviewing, testing and implementing new methods. Over the past years he has led the development of signal signal detection tools, such as the eRMR, with particular focus on new approaches in pregnancy and paediatrics. During the recent pandemic he coordinated the COVID19 Vaccine Safety Monitoring group at EMA.

Representative Invited

Representative Invited

Mathieu  Lamy

Mathieu Lamy

Director Pharmacoepidemiologist, Sanofi, Belgium

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