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.

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.