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.

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.

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 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.

Dionne is based in the UK and works in MSD's Office of the Global Qualified Person for Pharmacovigilance (GQPPV). Dionne is MSD's PSMF Owner and supports various key Global/EU and UK QPPV projects and tasks, such as EudraVigilance access, audits and inspections support and general project management, as needed. As a member of various PSMF industry groups, they share a keen interest in all things PSMF and the various approaches that companies take towards ensuring an efficient and compliant approach to PSMF management for the EEA, UK and globally.

Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

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 of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.