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Mercure Paris La Défense Grande Arche

Apr 19, 2016 12:30 PM - Apr 20, 2016 4:30 PM

17/20 Esplanade Ch. de Gaulle - Rue des Trois Fontanot, 92000 Nanterre/Paris, France

How to Prepare for PhV 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 of the audit/inspection.

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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