Gonzalo Calvo is the Head of the Department of Clinical Pharmacology at the Hospital Clinic of Barcelona and Associate Professor of Pharmacology at the University of Barcelona. Prof. Calvo’s main area of expertise is drug regulation, with particular interest in cardiovascular and onco-haematology. He has been principal investigator of around 50 clinical trials and has co-authored more than 100 peer-reviewed papers and 5 books. From 2002 to 2011, he represented the Spanish Agency on Medicines and Healthcare Products (AEMPS) at the EMA Committee for Human Medicinal Products (CHMP) as rapporteur of more than 60 new drug applications. Currently is Co-Chair of the EMA-HCPWP

Marieke De Bruin, PhD was trained as a pharmacist and epidemiologist. Her drug regulatory science research has focused on pharmacoepidemiology in the drug regulatory setting and pharmacovigilance. The main clinical areas are cardiovascular diseases and cancer. As of August 2016, she became professor in Regulatory Science at the University of Copenhagen and director of the Copenhagen Institute of Regulatory Science.

Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

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.

Bruce Guthrie is an academic GP researching how best to improve the quality and safety of healthcare, particularly in relation to prescribing, polypharmacy and multimorbidity.

Kaisa Immonen (MA) is responsible for the overall lead of EPF’s policy and advocacy work at EU level and key relationships with EU institutions and international organisations. She leads the thematic areas of empowerment, patient safety, and patient-centred care within EPF and is the current patient co-chair of the European Medicines Agency’s Patients and Consumers’ Working Party.

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority. She was elected in 2012 as the first chair of the European Pharmacovigilance Risk Assessment Committee and until 2023 was co-Chair of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.

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.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Dr.Christine Hallgreen associate professor at the Copenhagen Centre for Regulatory Science at the Faculty of Health and Medical Sciences of the University of Copenhagen, Denmark. She has a background is in engineering physics specialising in complex system dynamics and a have a PhD from Department of Physics at the Technical University of Denmark. In her research, she uses her quantitative and methodological training in the development and evaluation of drug regulatory tools and systems. Her research is motivated by a desire to describe and understand the functioning of the regulatory system, thereby optimising and improving the systems and regulatory tools set in place to promote public health.

Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

Daniel Morales is a General Practitioner and Epidemiologist at the University of Dundee and current member of the EMA Pharmacovigilance Risk Assessment Committee. His research interests include the use of real world data to support medicines regulation and safer prescribing, and has previously worked within the EMA Department of Pharmacovigilance and Epidemiology.

Sue is a professor of medicines’ management and health services’ research, and a community councillor. Her research influenced recommendations for lower doses of medicines in labour, and a concomitant improvement in UK breastfeeding rates. Her group is investigating implementation and sustainability of nurse-led adverse drug reaction profile checklists to identify, communicate and minimize any adverse effects of prescription medicines and optimize doses.

Nawab Qizilbash is: Head of OXON Epidemiology; Honorary Senior Lecturer in Epidemiology, London School of Hygiene and Tropical Medicine; Honorary Consultant Geriatrician, Madrid. Previously: Director of Clinical Epidemiology, GSK; Honorary Consultant Physician, Oxford. He leads long-term cohort analyses of cardiovascular risk factors and neurodegenerative diseases with Professor Stuart Pocock, London School of Hygiene and Tropical Medicine and is interested in multi-country hybrid field & field-database designs for the efficient evaluation of post-approval drugs.

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.

Rob has been Communications Coordinator at the European Patients’ Academy (EUPATI), a project on patient education and engagement in the research system, for more than 3 years. He has been part of Eurordis as consultant in patient group growth since 2008 and is working on surveys on patient satisfaction with clinical care. Rob was involved in the US AIDS Treatment Activists Coalition, and in its Drug Development Committee. Previously, at Treatment Action Group (TAG), he was the Antiretroviral Project Director for four years. Rob helped in implementing international patient advocacy and education in Europe. He worked with the European AIDS Treatment Group from 1995 – 2002.