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.

Marin Banovac is a pharmacist with an MSc in Clinical Pharmacology. After initial work experience in pharmaceutical industry, he worked for the Croatian Medicines Agency as a pharmacovigilance assessor and afterwards as an alternate member in Pharmacovigilance Risk Assessment Committee (PRAC). He was a seconded national expert at the EMA in Pharmacovigilance Department – Signal Management, later to join EMA as a Risk Management Specialist in Oncology, Haematology and Diagnostics Office. He is the coordinator of EMA Risk Management Community, and a lecturer in pharmacovigilance at Zagreb Faculty of Pharmacy.

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.

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.

Zaïde Frias has degrees in Pharmacy and Business Administration. Prior to joining the European Medicines Agency she worked in Pharmaceutical Industry. She joined the EMA in 1999; she was appointed Head of Human Medicines Research & Development Support Division in 2013 and Head of Head of Human Medicines Evaluation Division in 2016. In 2020, she took the position of Head of Digital Business Transformation Task Force. The Digital Business Transformation Task Force was created to drive complex, disruptive change initiatives that have a profound impact on the strategy of EMA, its operational structure and operation in relation to the EU medicines regulatory network, its partners and stakeholders.

Dr Roberto De Lisa, Clinical Pharmacologist, joined the EMA in 2006. Since then he held various positions in Medical Information and Pharmacovigilance working for the CHMP Pharmacovigilance Working Party (PhVWP) and the Pharmacovigilance Assessment Committee (PRAC). As of 2015 he joined the Paediatric Office working as Paediatric Coordinator with a special interest in paediatric pharmacovigilance. Prior to joining the EMA, Dr De Lisa worked for the University Hospital San Giovanni di Dio in Cagliari for 5 years, conducting clinical trials and participating in the activities of the local Ethic Committee and in the creation of the Pharmacovigilance Centre. He obtained a Master Degree in PharmacoEconomics from the University of Milan in 2005.

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 Eichorn did his medical training in the US and practiced general adult medicine in the outpatient and hospital settings for 10 years before joining the pharmaceutical industry. He joined Pfizer (UK) in 2002, and since then has served a number of roles in the safety, risk management and regulatory documentation functions, including overseeing production of clinical submission documents and aggregate reports, provision of cross-portfolio strategic guidance on RMPs, and advising on safety aspects of market research and patient support programmes.

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.

Dr Jordi Llinares is currently the Head of Research and Innovation at the European Medicines Agency (EMA). At the Agency he has had different posiitons including Head of Orphan Medicines, Scientific Support Development and, and Scientific and regualtory management between 2009 and 2020. Dr Llinares graduated as a Medical Doctor from the University of Barcelona and specialised (MIR) as clinical pharmacologist at Hospital Vall d’Hebron. He has a Masters in Science in Epidemiology from the London School of Hygiene and Tropical Medicine (London). Before joining the Agency he worked as clinical pharmacologist at Hospital de Sant Pau (Barcelona) and was member of the Ethics Committee of the IAS (Institut d’Assistencia Sanitaria).

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments, acquired scientific and regulatory expertise, communication, education and presentation skills, as well as a thorough understanding of project and budget management. She is an active member of the International Society for Pharmacoepidemiology with previous roles as Board member, VP Finance, and various committees. She is visiting professor of pharmacoepidemiology at the University of Bath in the UK.

Joined Industry more than 10 years ago after training in hospital medicine and neuro-immunology research in the UK. Interests from clinical practice include cardiology, neurology and rheumatology. Experience covering pharmacovigilance at all stages of lifecycle as well as multiple successful NDA and MAA submissions across major therapy areas. Currently leads a global group of Safety Physicians and Scientists across US and Sweden and covering therapy areas of Respiratory, Inflammation, Autoimmunity, Infection and Vaccines. James is actively involved promoting scientific thinking from basic sciences through to challenges of public health and real-world risk management.

Inge Zomerdijk has been in the pharmacovigilance department of MEB since 2010. A senior pharmacovigilance assessor and as a regulator has experiences in assessing Risk Management Plans, study protocols and results of evaluations of risk minimisation measures, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center, focusing on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry and remains involved in research.

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

David has been involved with providing input to R&D from a patient perspective for more than 20 years. He has played an active role in the European Patients’ Academy on Therapeutic Innovation (EUPATI), and currently co-leads their external Advisory Committee. He is a past co-chair of the Patient and Consumer Working Party at the European Medicines Agency.Currently, is involved with Swissmedic’s Patients and Consumer Working Group, and he is a member of the PFMD Executive Committee, of the Zurich Cantonal Ethics Committee and the Impact Council for Gilde Healthcare. As a past member of the DIA Regional Advisory Council for EMEA, he was awarded the Outstanding Contribution to Global Health award in 2019.