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.

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.