Ms Bocciarelli is a pharmacist with over 25 years of experience in pharmaceutical industry, mainly at Sanofi. Her primary area of expertise was pharmaceutical science, then international clinical quality assurance with a focus on pharmacovigilance quality and compliance including pre-approval inspections in clinical field for new drugs. She has the knowledge of the requirements and challenges of pharmacovigilance at both corporate and at country levels. Her experience includes quality management for drug surveillance pre- and post-marketing activities as well as clinical and pharmacovigilance audit activities: rationale, planning, process, performance and trending.

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.