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.

Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

Elsa has a Master Degree in Pharmaceutical Sciences. She worked five years as a Pharmacist. In 2013 she joined the Inspections Unit at INFARMED and is working as a Pharmacovigilance inspector since. Her core focus is on GCP/GVP/GDP/GMP, Internal Audits, Quality Alerts and Recalls, Shortages and Medicines Availability.

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.

Alexandra Szabó holds a Master in Pharmacy from the Semmelweis University in Budapest. She is the Lead of Medicines for Europe's Signal Work Stream and Head of Signal & Risk Management at Gedeon Richter Plc (headquarter of a mid-size, Central-European multinational pharmaceutical company). With her team, she is responsible for maintenance and supervision of the signal & risk management, PSUR, ACO, safety profile revision procedures, ensuring operation excellence and compliance with the concerned legislation and guidelines.

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

Dr. Harrison is the Chief Medical Officer of the MedDRA Maintenance and Support Services Organization (MSSO) where she is responsible for overall medical strategy. She has over 25 years’ experience in clinical research and pharmacovigilance, and is a member of the ICH M1 “Points to Consider” Working Group and the CIOMS Implementation Working Group on Standardised MedDRA Queries (SMQs).

With more than 25 years of experience in Pharmacovigilance, Christiane is currently the Global Head of Safety Signal Detection & MedDRA Query Mgmt. at Novartis, Basel, Switzerland. She was trained as a medical doctor in Frankfurt, Germany and obtained her MSc in Epidemiology and Biostatistics at McGill University, Montreal, Canada. She started her career in pharmacovigilance at Hoechst AG in Germany, worked later with Aventis Pharma in Germany as a senior safety physician and joined Novartis Pharma AG in Basel in 2002. Christiane is also a member of the CIOMS Implementation Working Group on Standardized MeddRA Queries (SMQs).

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly 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 Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.

Dionne works in the Office of the EU QPPV for MSD in the UK as the PSMF Owner. Interested in “all things PSMF” and other primary areas of support are EudraVigilance access management, PV Audits and Inspections and ad hoc EU QPPV Office projects and activities.

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

Andreas has a PhD in Chemistry and works in the pharmaceutical industry since 1996 in the fields clinical research, biostatistics and pharmacovigilance. In 2008 he joined STADA and became Head of Global Pharmacovigilance Unit and EU QPPV Backup in 2013.

Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

Attila Olah graduated as a Medical Doctor in University of Debrecen (Hungary) in 2005. Attila has 10+ years PV experinece in pharma industry. He worked in Gedeon Richter and Novartis where he has held several PV roles with increasing responsibility. He is currently acting as the Head Global Phramacovigilance and EU-QPPV in Gedeon Richter.

With his team, he is responsible for overseeing i) the data collection, management and analysis activities related to the EudraVigilance system to support signal detection activities, ii) the EudraVigilance quality assurance framework and iii) all the processes related to the Medical Literature Monitoring (MLM).

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.