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 is currently 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’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.