Peter got his medical degree from the Catholic University of Leuven in Belgium and until the end of 2003, Peter practised as a General Practitioner in the UK. In 2004, he joined Roche as a drug safety physician in the local organisation. Taking up roles with increasing responsibility, Peter was appointed Qualified Person for Pharmacovigilance for Roche in 2011. He left Roche at the end of 2014 to take a role at Daichii Sankyo and moved on to be the Head of Global Drug Safety & QPPV for Grunenthal. Peter has extensive experience in pre-approval and post-marketing pharmacovigilance.

After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, ISoP Board Member and VP in the Alliance Clinical Research Excellence and Safety (ACRES) . He chairs the unique Pharmaceutical ergonomics & human Factors Group in the UK. After 14 years at NDA Regulatory Science Ltd, he has his own pharmacovigilance consultancy Husoteria Ltd

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.

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.

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.

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Big Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group and Member of the ACT EU Steering Group In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London

Dr. Brigitte Keller-Stanislawski has studied medicine in Münster and Frankfurt and is consultant clinical pharmacologists. Since 1994 she is working at the Paul-Ehrlich-Institut (PEI) in Germany. She is head of the Department Safety of Medicines and Medical Devises in the PEI. Brigitte Keller-Stanislawski is co-opted member of the Pharmacovigilance Risk Assessment Committee and member of the Vaccine Working Party of the European Medicines Agency.

Geo Pajovich is currently Vice President, Head of Product Safety Surveillance and Reporting within the Pharmacovigilance group at Pfizer, Inc. His main responsibilities include systems and processes for ICSRs and aggregate reports. Geo holds a bachelor of Science degree in Pharmacy with over 22 years of experience in Signal Detection, Risk Evaluation and Risk Management, adverse event reporting, Project Management, quality systems, audits/inspections, and training within the pharmaceutical industry.

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 30 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics. Founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical, biotechnology and medical device industry, focussing on B/R product assessment, PV system performance and organisational excellence. She has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts for more than 12 years.

Sue has been in the pharmaceutical industry for over 25 years. Sue joined Amgen in 2013 as EU QPPV. Sue works closely with the Global Patient Safety team and a network of local safety officers to provide oversight of patient safety across the EU. Sue sits on the Efpia Pharmacovigilance Expert Group and is an honorary Fellow of PIPA (Pharmaceutical Information and Pharmacovigilance Association). Prior to joining Amgen Sue spent 3 years at Eisai Europe Ltd as Head of International Pharmacovigilance and EU QPPV having previously held various roles in safety, medical information and marketing for GlaxoSmithKline and AstraZeneca operating at both the affiliate and global level. Sue holds a BSc (Hons) in Biochemistry and MSc in Immunology.

John Barber is since approximately 25 years in the pharmaceutical industry, the last 10 years in pharmacovigilance. He is the past President of the UK Pharmaceutical Information and Pharmacovigilance Association (PIPA)(2005-09), Lead on pharmacovigilance for the British Generic Manufacturers Association (BGMA) and a current member of the European Generics Association's (EGA) Pharmacovigilance Working Group leading the RMP work stream. His prior roles were with ICI Pharmaceuticals, Glaxo Wellcome, Roche and PharmaVentures, 2000 to 08, he was the Director of Scientific Affairs at Alliance Pharmaceuticals. He then became the Global Clinical Pharmacovigilance Manager at Glenmark Pharmaceuticals, 2008-10. Since 2010, he’s the QPPV at Dr Reddy’s.

Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance.

Danie du Plessis was appointed Senior Vice President, Head Worldwide Medical Affairs at GSK in November 2015 after joining the company in May 2010. He previously worked for Eli Lilly & Company for 17 years in different roles and has worked in South Africa, Australia and the UK. Danie holds a Medical Degree from the University of Stellenbosch, a Masters degree in Pharmacology from the University of the Free State in South Africa and an MBA from the Edinburgh Business School in Scotland.

Expert in Pharmacovigilance and Drug Safety. European Medicines Agency (EMA) scientific administrator responsible for performing signal management activities for centrally and nationally authorized products, providing support to (Co)- Rapporteurs and Scientific Committees and contributing to scientific projects in the area of pharmacovigilance and signal management. EMA Emerging Safety Issues (ESIs) coordinator and responsible for the EU-NTC PhV Training Curriculum design, implementation and its maintenance.

A qualified Physician, she worked in Germany, Switzerland and Italy as GP and in emergency medicine. She joined the pharmaceutical industry in 1999 and worked in Clinical Pharmacology, Drug Development and Pharmacovigilance and is now the EU QPPV for Gilead. She has experience across a wide range of therapeutic areas, currently focused on infectious diseases and oncology. She obtained her MD from Queen Mary, Bart’s & the London and is a Senior Lecturer at King’s College London and also regularly teaches at the DSRU on Pharmacovigilance, Risk Management and Biotechnology topics.

Rebecca is the Director of Pharmacovigilance Quality Assurance at AbbVie, having joined in January 2016. Prior to this Rebecca spent 10 years at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in variety of operational roles within the Vigilance and Risk Management of Medicines division and later as a Senior Pharmacovigilance Inspector within the Inspection, Enforcement and Standards division.

Esteban has worked in both academia and industry in a range of roles including academic research, drug discovery, pharmacovigilance and regulatory policy. Before joining AbbVie, Esteban was Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) as well as working in pharmacovigilance for P&G Pharmaceuticals and drug discovery for Novartis. He holds a Biochemistry BSc from Warwick University, PhD in virology from University College London, and has worked as a postdoctoral researcher at Imperial College London

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

Xavier Kurz graduated in 1982 as a Medical Doctor at the University of Liege, Belgium. He specialised in Tropical Medicine and worked for several years in public health projects in Africa and Asia. He obtained a MSc (1991) and a PhD (1997) in Epidemiology and Biostatistics at McGill University, Montreal, Canada. He then joined the Department of Pharmacology of the University of Liege and the Belgian Centre for Pharmacovigilance (Ministry of Health) as scientific expert. He joined the European Medicines Agency (EMA) on 1st September 2005. He is currently leading the Data Analytics team within the Data Analysis and Methods Task Force.

Andrew is currently the Head of the QPPV and Alliance Office at Grünenthal in Aachen, Germany. He provides oversight to the QPPV on the global pharmacovigilance system on matters relating to audits and inspections, infrastructure, key processes, compliance metrics, safety profiles and safety issues related to Grünenthal’s medicinal products. Before joining Grünenthal, Andrew was Pharmacovigilance Manager at ProductLife In Cambridge, UK. He has a Ph.D in Biochemistry from Cambridge University, and he has professional and academic experience working in research laboratories.

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.

Guy Demol is the European Qualified Person for Pharmacovigilance (EU QPPV) for MSD since October 2013. Previously, he was Vice President Development for sanofi pasteur MSD (SPMSD) as of 2009. As such he was leading SPMSD’s activities in Clinical Research, Epidemiology, Regulatory Affairs, Pharmacovigilance and Risk Management, and Quality and Pharmaceutical Affairs. He joined SPMSD in 2007 as Executive Director Pharmacovigilance and Risk Management and EU QPPV. Before joining SPMSD, he was the franchise head for vaccines in the European Regulatory Affairs Department of MSD in Brussels.

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.

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.

Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.

Kristina studied medicine at Cambridge and London Universities in the UK. She has 28 years Clinical Development and Drug Safety pharma experience in the UK, Switzerland and Germany. She lectures in pharmacovigilance on various courses in the UK, and is an examiner for the Faculty of Pharmaceutical Medicine. She is a Member of The Royal College of Physicians UK, a Fellow of The Faculty of Pharmaceutical Medicine, and holds specialist registration in pharmaceutical medicine with the GMC in the UK.

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.