Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years) and CRO (9 years). Following her MSc in Epidemiology from LSHTM, she co-developed their course in PhV and Pharmacoepi. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU strategy and policy on risk management, was lead writer on the EU guidelines on this and was part of the core team implementing the 2010 PhV legislation and ENCePP. She is/was on the CIOMS IX/XI/XIII working parties and is a member of the CIOMS Executive Committee.

He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.

Anne Ambrose is an Expert Pharmaceutical Assessor and Specialist in Post Authorisation Operations and Safety Issues in the Vigilance and Risk Management of Medicines (VRMM) Division, MHRA, UK. She is a qualified pharmacist and has worked in hospital and retail pharmacy and the pharmaceutical industry. She worked for a number of years in Regulatory Affairs in the pharmaceutical industry before joining the Medicines Control Agency (now MHRA) in January 1995 as a pharmaceutical assessor. Anne was a UK expert to CMDh 2005-2020 and was involved in various CMDh working groups and was chair of the CMDh Working Party on Pharmacovigilance Procedures Worksharing (formerly EU PSUR Work Sharing Group) 2010-2017.

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology, and a faculty member at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences at the University of Southern California. Meredith has been an invited participant in numerous risk management workshops and panels sponsored by the US FDA, and has served as a member of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products, CIOMS XI Patient Involvement in the Development and Safe Use of Medicines and IMI-PREFER.

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.