Prof Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He is Visiting Professor, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, was Project Coordinator for the IMI WEB-RADR 2 consortium, and is Work Package Co-Leader for IMI ConcePTION.

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) 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, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

Hedvig Nordeng is a professor and Head of Pharmacoepidemiology and Drug Safety Research Group, Dept of Pharmacy, University of Oslo (Ui0), Norway. Also Head of PharmaTox Strategic Research Initiative at Faculty of Mathematics and Natural Sciences, and Head of the Norwegian PhD School of Pharmacy. Her expertise lies within perinatal pharmacovigilance and pharmacotherapeutics in pregnancy and breast-feeding women. As of 2018, PRAC independent scientific expert, (re)appointed by the European Commission (with 2nd mandate up to July 2024). Member of ENTIS, executive committee member of NorPEN, chair of the Medication in Pregnancy and Lactation special interest group at the International Society of Pharmacoepidemiology (ISPE) and fellow of ISPE.

Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.

Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.

Dr Alexis Nolte worked as a research scientist in the field of RNA molecular biology and RNA combinatorial biochemistry. In 1999 he joined EMA as Scientific Administrator in Quality of Medicines with focus on innovative technologies. He was also a member of the Agency’s Innovation Task Force and involved in the implementation of several regulatory initiatives. During his time at EMA he acted as Head of the newly created Sector of Product Data Management, was appointed Head of Quality of Medicines, became the Head of Procedure Management and Business Support, then the Head of the Information Management division and in 2020, Dr Nolte was appointed Head of Human Medicines Division which oversees human medicines throughout their lifecycle.

Maria Giovanna Satta obtained a Master’s degree in Pharmacy from the University of Sassari, an MSc in Pharmacovigilance from the University of Florence and later specialised in Hospital Pharmacy. After over 12 years of experience in the pharmaceutical industry, covering several roles and responsibilities mainly focused on drug development and risk management, she joined the European Medicines Agency (EMA) in 2015 as Risk Management Specialist (RMS) in the Oncology, Haematology and Diagnostics (ONC) office. In 2017 she was appointed as RMS in the office of Therapies for Neurological and Psychiatric Disorders (H-NEU), where she currently works. Additionally, she coordinated EMA Risk Management Community (RMC) from 2019 until recently.

Liana Gross-Martirosyan has been with Medicines Evaluation board since 2012 in the field of pharmacovigilance. Since 2008 she is the alternate PRAC member from the Netherlands. Liana is a medical doctor and holds MPH degree and PhD in pharmacoepidemiology. Special interests of Liana include interventions in clinical practice to minimize the drug safety risks and evaluation of additional risk minimization measures’ effectiveness.

Daniel Morales is a General Practitioner and Epidemiologist at the University of Dundee and current member of the EMA Pharmacovigilance Risk Assessment Committee. His research interests include the use of real world data to support medicines regulation and safer prescribing, and has previously worked within the EMA Department of Pharmacovigilance and Epidemiology.

Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s strategic priority to facilitate the uptake of advanced manufacturing approaches in EU and is part of the ICMRA PQKMS group. She has trained as a pharmacist in the School of Pharmacy of the University of Athens and has received a M.Sc. and a Ph.D. in Pharm. Technology from the same Faculty.

Raymond Anderson, BSc(Hons) FPSNI FCPA FFRPS. Over 40 years experience working as a community pharmacist in Portadown, Northern Ireland. Raymnod has held a wide range of professional and non-executive positions including; President of the Pharmaceutical Society of Northern Ireland and President of the Commonwealth Pharmacists Association. He currently sits on the the EMA’s Pharmacovigilance Risk Assessment Committee, appointed as a Healthcare Professional representative by the European Commission and is the N.Ireland delegate to PGEU (Pharmaceutical Group of the European Union). He is a Fellow of the Pharmaceutical Society of N. Ireland, the Commonwealth Pharmacists Asscoiation and the Faculty of the Royal Pharmaceutical Society.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks 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 and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Adrien Inoubli currently represents France in the pharmacovigilance committee (PRAC) of the European Medicines Agency (EMA). Pharmacist by training, with a master degree in public health (2018 London School of Hygiene and Tropical Medicine), and a master degree in medicines regulation (2013 University of Strasbourg), he has 10 years of experience working in medicines regulatory agencies (MHRA, ANSM and EMA) to ensure the safety, efficacy, and quality of medicines.

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 a medical doctor, clinical pharmacologist by specialisation who holds a PhD in Pharmacogenomics applied to Biosciences and a master’s in Clinical pharmacology (pharmacokinetics). More than 20 years’ experience as a clinical pharmacologist and pharmacovigilance specialist, both in university hospital and in the medicines regulatory authority in Croatia working at the positions of a clinical and pharmacovigilance assessor, head of the PV department, national PRAC and CHMP member at the European medicines agency (EMA) and served for four years as the director of the Croatian medicines agency (HALMED). Currently at EMA as the PRAC Scientific Committee Lead and Scientific adviser on safety of medicines in the PV office.

Dr Ulla Wändel Liminga is a pharmacist, and has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Medical Products Agency (MPA), Sweden, as a non-clinical assessor. She has since then worked with non-clinical as well as clinical efficacy and safety assessments. In 2007, she became Scientific director pharmacology and toxicology at the MPA, and in March 2020, her position has changed to Scientific director pharmacovigilance. From July 2012, she has been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency.