Dr. Irina Caplanusi is qualified as medical practitioner. She joined the European Medicines Agency in 2009 and is currently working as Signal Management Lead in the Pharmacovigilance Department. She has broad experience in signal management (leading on Signal Procedures at the Pharmacovigilance and Risk Assessment Committee) and incident management (including Emerging Safety Issues and the Incident Management Plan). In the recent years she worked extensively in the pharmacovigilance of COVID-19 vaccines, from safety monitoring to leading on high profile signal procedures.

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

With 10 years in research and >30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology and drug safety

Sabine Brosch was appointed DPO at EMA in January 2022. She joined EMA in 1996 and has been working in pharmacovigilance, clinical trials and international harmonisation (ICH) and standardisation (ISO) focusing on the development of the Individual Case Safety Report and Identification of Medicinal Products standards as well as the medical terminology MedDRA. She holds a master’s degree in pharmacy and a doctor of natural sciences degree of the University of Vienna, Austria.

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.

Main roles and responsibilities are within the signal management activities in the EMA Pharmacovigilance Office; to conduct of ad-hoc queries and related data analyses based on requests from (Co)-Rapporteurs, EMA’s Scientific Committees and relevant Working Parties in the context of product related safety issues using EVDAS; to provide expert advice to EMA product teams on pharmacovigilance/signal detection and management issues; to support the implementation of the EV Access Policy and address requests related to access to information/documents from EV; to support the implementation of the Pharmacovigilance legislation. Rodrigo is co-chair of the EudraVigilance Expert Working Group.

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. She was the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC) from 2012 till 2018 and acted as PRAC chair from July 2018 till July 2024. She also 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.

Dr Martin Huber is the Vice Chair of the Pharmacovigilance Risk Assessment Committee (PRAC) and has been a member of the Pharmacovigilance Working Party (PhVWP) before. He has been actively involved in many pharmacovigilance procedures including important referrals at PRAC and also contributes to the work of several working groups at the European level. Being a pharmacist by training and holding a degree in public health he gathered detailed experience in pharmacovigilance in a hospital setting before entering BfArM in 2010. Since 2013 he is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors'.

Gianmario Candore is a statistician by training who has been working at the European Medicines Agency since 2009. Over the last years he has been involved in different projects on observational research and is now leading the real word data transformation to support regulatory decision-making. He is also co-chair of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®).

Dr Dave Lewis is Visiting Professor of Pharmacovigilance within the School of Life and Medical Sciences at the University of Hertfordshire, UK. Dave worked for over forty years in Patient Safety and Pharmacovigilance at GSK, Shire and Novartis. He was an active contributor to the ICH E2B (electronic reporting) and E2D (post-marketing data management) Expert Working Groups. He led the Innovative Medicines Initiative WEB-RADR project focusing on pharmacovigilance and social media, and was Co-Lead for Work Package 2 of the IHI ConcePTION project, researching pharmacovigilance in pregnancy and breastfeeding. PUBLICATIONS: Bibliography of ~40 publications on pharmacovigilance can be provided upon request.

Main roles and responsibilities are with the implementation of the EudraVigilance database and international standardisation development through involvement with ICH, ISO and HL7. This also involves providing technical and practical advice to Marketing Authorisation Holders, National Competent Authorities and Sponsors of Clinical Trials on how to implement IT systems to submit data on Adverse Drug Reaction reports electronically to the EudraVigilance database.

Alison Turney, PharmD Dr. Turney is a Surveillance Business Process Advisor in Global Patient Safety (GPS) at Eli Lilly and Company. She is responsible for coordination of activities and processes within GPS and between GPS and global and local functions within the company to maintain compliance with regulatory requirements worldwide. Alison has over 15 years of experience in Pharmacovigilance and is responsible for the strategy and development of processes to enable appropriate characterization and communication of the benefit risk balance of products for patients including Post-Marketing Safety Surveillance, the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER).

Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being Expert GVP Inspector. She contributed to the development of the EU GVP Modules, had a role in the training of GVP Inspectors in other EU Member States and contributed to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. Before joining the MHRA, Kiernan worked as a certified QA auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree.