Diane Hallé has more than 16 years of experience in PV for regulatory aspects, quality system and compliance, as well as for operational and project management activities. She held various positions at the French Agency as a regulatory assessor in PV, an evaluator in PV, then for more than 10 years as an inspector in PV, with more than 100 PV inspections to her credit. In particular, she was a member of the European Pharmacovigilance Inspectors Working Group (PhV IWG) as well as participated in the development of European and French PV regulations. She was working for ALNYLAM, a leading biopharmaceutical company in RNAi, within the Global PV Quality Assurance team dealing daily with PV audits and PV inspection readiness activities.

Dr. Lungu has over 30 years of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.