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.

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.

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. Peter Arlett leads the Data Analytics and Methods Taskforce at the European Medicines Agency (EMA), overseeing clinical evidence, real-world data, AI, and safety reporting. He chairs the EMA Data Board and co-chairs several key groups, including the HMA-EMA Big Data Steering Group and the Vaccine Monitoring Platform. Before joining EMA in 2008, Dr. Arlett worked at the European Commission, served as a UK delegate to the European Committee for Human Medicinal Products, and held roles at the MHRA. He trained as a physician in Oxford and London, holds a medical degree from University College London, and is Honorary Professor at the London School of Hygiene and Tropical Medicine.

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.

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 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.

Mr Subhash Mistry is working since 30 years at GlaxoSmithKline with last 26 years in the Pharmacovigilance Department with increasing roles of responsibility to aid in the management of Patient Safety. He represents the E2B Informal Stakeholders forum at the Eudravigilance Expert Working Group. The Stakeholders group look to share their experiences in implementation of electronic safety reporting and Eudravigilance related activities across a diverse set of Pharma companies (incorporating multinationals and SME companies) both based in the EU/EEA and outside of this region.

In her position as Head of Service E, Irene is responsible for ensuring the quality and consistency of PRAC recommendations, CHMP opinions and CMDh positions and their respective assessment reports for PSURs, PSUSAs and PASS procedures. In addition, the service provides regulatory and procedural support on these procedures to the network, as well as external stakeholders. Irene is also the EMA business lead of the PSUR repository project.

After studies in biology, Steven worked for several pharmaceutical companies before joining Merck Research Laboratories in 1985. He has over 28 years of experience in pharmacovigilance. Currently he leads an Aggregate Reporting Group whose responsibilities include the strategic and operational oversight for the preparation of aggregate safety reports including PSURs and DSURs. Steven has lectured about PSURs at several DIA and and Pharmaceutical Education Reseach Institute courses. He prepared the initial drafts of the sample comercial sponsor’s DSUR included in CIOMS VII.

Medical doctor, trained in clinical pharmacology, joined the EMA in 2010 and works in Data Standardisation and Analytics service. She is the lead scientific administrator for activities related to the European medicinal products dictionary (Art 57 database) and recoding of safety reports medicinal product information.

After studies in clinical research and development, specialising in Clinical data management, Francois worked for pharmaceutical companies in various position in clinical data management. He joined the European Medicines Agency in 2009 where he works in the Data Standardisation and Analytics service of Information Management Division. He is the project manager of the EudraVigilance Auditable Requirements project, set-up to complete the implementation of the new Pharmacovigilance legislation and to deliver the new EudraVigilance system. He is also supporting all activities related to the data management and analysis of the EudraVigilance (EV) system in particular using the EudraVigilance Data Analysis System (EVDAS) and SAS.

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.

Tom Paternoster-Howe joined the EMA in 2004, where he has worked ever since. His work at the EMA has focused on the quality and analysis of data in Eudravigilance and he is currently the lead scientific administrator for both the Medical Literature Monitoring service & the Eudravigilance data management contract. Prior to joining the Agency, he worked for 3 years in the industry & at the MHRA in pharmacovigilance.

• Brief employment history: Working in Sanofi pharmacovigilance for over 10 years, first in case management unit, then in the clinical management product unit and in the periodic report unit. She joined the literature surveillance team in 2012 as Literature Surveillance Assistant and took over the team leader responsibility in September 2013. • Professional highlights: PhD in cell biology, Expertise in clinical study-related pharmacovigilance activities, periodic safety report writing, Expertise in literature searches and process, transverse management of literature-related activities

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation procedures. Ana has been Programme Manager for the Accelerating Clinical Trials in the EU (ACT EU), a European clinical trials transformation initiative which is co-lead by EC, HMA and EMA, and is currently the Head of the Clinical Trials Transformation workstream at EMA.