Dr. Enrica Alteri is a Doctor in Medicine and Surgery from the University of Rome “La Sapienza” and holds post graduate qualifications from the National Cancer Institute USA and EUCOR/ECPM. Dr. Alteri has many years of experience from within the pharmaceutical Industry, specifically in the areas of drug discovery, clinical safety and pharmacovigilance. Dr. Alteri joined the European Medicines Agency as Head of Safety and Efficacy on 02 July 2012, which was followed by her appointment as Head of Human Medicines Evaluation Division in August 2013. On 01 September 2016 Enrica was appointed Head of Human Medicines Research & Development Support Division.

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 centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.

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 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.

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).

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority. She was elected in 2012 as the first chair of the European Pharmacovigilance Risk Assessment Committee and until 2023 was co-Chair of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.

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.

Željana Margan Koletic joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED) five years ago as an assessor in the pharmacovigilance department. She graduated in 2010 from the Faculty of Pharmacy and Biochemistry at University of Zagreb and she worked for several years as a community pharmacist. She participated in several pharmacovigilance projects and was a guest lecturer at University of Zagreb. Currently, she is working as Principal Coordinator for PSUR, DSUR and RMP assessment at HALMED and she is finalizing her thesis about biologicals and biosimilars at postgraduate specialist study “Clinical pharmacy” at University of Zagreb. Since 2016 she is a Croatian member of Pharmacovigilance Risk Assessment Committee.

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. Lilienthal is the German Pharmacovigilance Lead Assessor in the area of Oncology/Immunology and joined BfArM in 2011. In this role he is actively involved in many steps of the signal management process. He was further appointed as Lead Assessor in various Pharmacovigilance procedures. In addition, he contributes to internal and external pharmacovigilance trainings and occasionally joins pharmacovigilance inspections. Dr. Lilienthal graduated as MSc in Molecular Biotechnology with a focus in Oncology/Immunology, holds a degree in Business Administration and PhD in Life Science. Since 2013 he is also deputy head of the unit 'risk management I' in the Pharmacovigilance Department of BfArM.

Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management