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".

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 is an MD specializing in clinical pharmacology, with a PhD in pharmacogenomics and a master's degree in clinical pharmacology with 20+ years of experience in clinical pharmacology, pharmacovigilance, and regulatory affairs. She served as clinical and pharmacovigilance assessor, head of PV, national PRAC and CHMP member, and finally as the director at HALMED, overseeing the integration into the EU medicines network upon Croatia's accession to the EU. After 2 yrs secondment at the EMA in scientific advice office followed by supporting pharmacovigilance systems globally at the WHO, she is since 2019 based at the EMA in Amsterdam, where she serves as PRAC Scientific Committee Lead and Scientific Adviser on medicine safety.

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 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.

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.

Charlotte Bakker is a medical doctor, clinical pharmacologist and holds a PhD in early phase drug trials. In 2020 she joined the European Medicines Agency (EMA) and currently works as signal management lead in the Quality and Safety of Medicines Department. She has a particular interest in the safety of medicines during pregnancy and breastfeeding. Over the past few years, Charlotte has been actively involved in EMA’s activities related to this topic.

Anna holds a PhD and is a 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.

Stephanie Ernst is an author, researcher, and expert patient bridging the gap in the multiple birth world, connecting the medical community with families and lived experience. Her advocacy stems from her reality as a parent to preterm, monochorionic twins born at 31 weeks with Twin Anemia Polycythemia Sequence (TAPS). This background led her to found a nonprofit dedicated to twin complication research, ensuring families have direct access to evidence-based insights while fostering collaboration between clinicians and patients. Stephanie also serves on the Patient, Parent and Public Advisory Board of the European Standards of Care for Newborn Health (ESCNH), an initiative of the Global Foundation for the Care of Newborn Infants (GFCNI).

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.

Peter is a hospital pharmacist and researcher focused on medication use during pregnancy and lactation. He is particularly interested in clinical pharmacological decision-making, including distinguishing medication effects from those of underlying conditions. His work centers on psychotropic and antiseizure drugs. During his internship at SickKids Hospital in Toronto, he established a clinical service providing evidence-based guidance to patients on medication use in pregnancy and lactation, which continues today. His research uses real-world data to study medication exposure, maternal and neonatal outcomes, ADHD medication safety, and drug effects on human milk.

Marleen van Gelder is assistant professor in pharmacoepidemiology at the Radboud university medical center and senior researcher in pharmacoepidemiology at the University of Oslo. She has 15+ years of experience in initiating, conducting, and supervising projects on the effects of pre-conceptional and prenatal medication use on maternal and child health outcomes. This encompasses both methodological and clinical studies using registry data or data obtained through primary data collection. Her work focusses on commonly used medications (e.g., analgesics, antidepressants, asthma medication, and PPIs) and outcomes (e.g., miscarriage, gestational diabetes, preeclampsia, preterm birth, and neurodevelopmental outcomes).

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.

Catherine Cohet, PhD, is Senior Pharmacoepidemiologist in the EMA Data Analytics & Methods Task Force. With 20+ years academic, industry, and regulatory experience, she specialises in real world evidence generation and use, including key roles in ICH guideline development (M14, E6(R3) Annex 2) and the EU Vaccine Monitoring Platform. She co chairs the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), represents EMA in working groups of the International Coalition of Medicines Regulatory Authorities, and advises the WHO Global Advisory Committee on Vaccine Safety. She previously worked in industry, as well as in public health in New Zealand and at the WHO International Agency for Research on Cancer in France

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.

Charlotte Root is Director of Safety & Pharmacovigilance at ViiV Healthcare. She serves as secretariat for the safety governance and labelling committee and oversees safety evaluation and risk management activities for key assets. She contributes to ViiV Healthcare’s efforts to accelerate pregnancy data generation through her role on the ViiV Pregnancy Working Group and by supporting the practical integration of these approaches into development processes. Charlotte has 26 years of pharmacovigilance experience across GSK and ViiV, spanning multiple therapy areas, and has focused on HIV prevention and treatment since 2014.

Dr Annemiek de Ruiter is Head of Global Medical Sciences at ViiV Healthcare and an Honorary Consultant Physician in HIV at Guy’s & St Thomas’ NHS Foundation Trust, London. With more than 35 years of experience in HIV care, she established and led the service for women living with HIV at GSTT, serving many migrants from Sub-Saharan Africa. She led the British HIV Association Pregnancy Guidelines (2008-2014), joined ViiV Healthcare in 2016, and became Head of Global Medical Sciences in 2018. She also chairs ViiV’s Pregnancy Working Group. Annemiek continues to care for people living with HIV and lectures globally on the impact of psychosocial factors and stigma in HIV care.

Mathieu Lamy is a senior director in pharmacoepidemiology at Sanofi with over a decade of experience designing observational studies. In his role he designs and conducts Post-Authorization Safety Studies (PASS), focusing on prospective primary data collection. He holds an MPH in epidemiology from the Bordeaux University (ISPED) and previously worked in the industry with GSK Vaccines and in the public sector for the French national public health agency (ANSP), for the Pasteur Institute and for NGOs such as MSF where he led Global Health studies in field epidemiology across multiple settings and continents.