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.

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.

Physician and pharmacovigilance leader with more than 26 years of experience as a senior regulator, QPPV, auditor, trainer, and serial entrepreneur. Working in intelligent automation in PV for over 10 years, with the last 4 years dedicated to hands-on development and implementation of generative AI and AI agents in PV operations, including the validation of such systems and their defence before auditors and inspectors. Faculty member of DIA’s AI in PV training course and lecturer at the European Course in Pharmaceutical Medicine. Fellow of the International Society of Pharmacovigilance. Educated at Charles University in Prague, Imperial College London, with additional executive education in business and agentic AI from Harvard and MIT.