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.

Maarten Lagendijk is currently Deputy EU QPPV at MSD. Previously he has held different positions in pharmacovigilance at the Medicines Evaluation Board (MEB), the Dutch Regulatory Authority, with increasing responsibilities. With over 15 years of experience in pharmacovigilance, Maarten has a good understanding of all different aspects of safety and risk evaluation of medicines in a broad range of therapeutic areas, most notably in oncology and hematology, as well as in immunology and pulmonology. Through the years he has also focused on developments around risk communication and additional risk minimisation, as well as the evolution of risk management and efforts to streamline and harmonise risk management plans.

Stephanie is Head of the Immunology, Biocompatibility and Non-clinical team in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and pharmacovigilance.

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

Kaat Bollaerts is a methodologist/statistician with a passion for epidemiology. She obtained her master in theoretical psychology at Leuven University (Belgium) in 2001, a master in statistics in 2004 and a PhD in statistics in 2009, both from Hasselt University (Belgium). After obtaining her PhD, she started working as a senior scientist at Public Health, Belgium. In 2013, Kaat joined P95 to work on the ADVANCE project on Accelerated development of vaccine benefit-risk collaboration in Europe. Throughout her professional career, she was involved in consulting activities for private industry, governments and (inter)national public health institutions.

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.

Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and having now been there over 13 years, Katherine leads their epidemiology team working closely with partners across the Agency to advise on the value of observational studies and to develop strategy on the use of real world data to support regulation. She has particulalr interests in the use of RWE to support pharmacovigilance, vaccines safety, and the role of observational data in evaluating the safety of medical devices.

Steve Hobbiger obtained a BSc in Physiology before qualifying in Medicine. He joined Wellcome in 1989 and spent ten years at Wellcome/GlaxoWellcome in Clinical Research. Following a period at Napp, Steve returned to GSK in 2001 to work in Pharmacovigilance. He became QPPV in 2009 and is currently Head of Safety and Medical Governance. Steve is Chair of the GSK labelling committee, Co-Chair of the GSK Global Safety Board and a past Vice President of the FPM

Olga developed her Medical degree in the University of Navarra and her training as Clinical Pharmacologist in Madrid, San Carlos Hospital. In 2002 joined CINFA for the clinical development of diverse generic medicinal products, and in 2007 was appointed as EU-QPPV. As head of Pharmacovigilance of the leader in Spanish generics market, she established the pharmacovigilance system compliant with the EU GVP, and adapted the system to the local regulation in the regions where the company is also present through distribution channels, in Central America, Francophone Africa and Middle East. She is active member of the Pharmacovigilance working group of Medicines for Europe, and the Spanish Generics Association.

Dr Shahrul Mt-Isa is a senior statistician at the School of Public Health, Imperial College London. He has a width of experience and interest in benefit-risk assessment, decision analysis, evidence synthesis and data visualisation, as applied in pharmaco/-epidemiology & clinical trials. He works on PROTECT Benefit-Risk project for the past 5 years. He co-led the BR assessment methodology, visual representation reviews, BR training and website development (http://www.protectbenefitrisk.eu/).

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Doris Stenver is the founder of Unique Advice and she is specialised in internal medicine and has a master degree in public administration. She is former Chief Medical Officer at the Danish Medicines Agency and former member of the EU Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

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.

Maria qualified in Medicine from Cambridge University and became an Anaesthetist, working in the UK National Health Service. Her early industry career included roles in phase I clinical trials and in PET imaging as part of the GlaxoSmithKline Translational Medicine team. In 2004 joined the Global Clinical Safety & PV department, working in the neurosciences area and managing a team providing clinical safety for a portfolio of investigational & marketed products. In 2012, she became Deputy EU QPPV and in 2016 she joined AstraZeneca as Deputy EU QPPV. In 2019 Maria moved roles into therapy area-aligned clinical safety. She is now responsible for clinical-strategic leadership for assigned products in the oncology area.

Inge Zomerdijk has been in the pharmacovigilance department of MEB since 2010. A senior pharmacovigilance assessor and as a regulator has experiences in assessing Risk Management Plans, study protocols and results of evaluations of risk minimisation measures, national implementation of risk minimization measures as well as benefit-risk assessments of both new drug applications or post marketing follow up. In 2015 she completed her PhD research at the Erasmus Medical Center, focusing on how to evaluate risk minimization measures, the impact of these measures on the benefit-risk balance of drugs and translating possibilities and challenges to practical implications for regulatory authorities and industry and remains involved in research.