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Advanced Pharmacovigilance Audits and Inspections Virtual Live Training Course

Course participants will learn how to prepare for the audit inspection. They will learn all aspects of best practice, spanning the time from the notification of the audit visit up to the receiving the results and conclusions.


Faculty

  • Calin A. Lungu, MD

    Calin A. Lungu, MD

    • CEO
    • Drug Development Consulting Services S.A. (DDCS), Luxembourg

    Dr. Lungu has more than 15 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted almost 150 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 training programme and led more than 300 offerings since 2004.

  • Patricia  Bocciarelli

    Patricia Bocciarelli

    • International Pharmacovigilance Expert
    • Marta Gersberg Conseil, France

    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.

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