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Adina Apartment Hotel Berlin Checkpoint Charlie

Mar 12, 2018 8:00 AM - Mar 13, 2018 4:30 PM

Krausenstrasse 35-36, 10117 Berlin, Germany

How to Prepare for Pharmacovigilance Audits and Inspections

This course will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement to the conclusion.

Faculty

Patricia  Bocciarelli

Patricia Bocciarelli

International Pharmacovigilance Expert, P.SUPP Consultant, 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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