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Hotel Bildungszentrum 21

Oct 14, 2019 8:15 AM - Oct 15, 2019 9:15 AM

Missionsstrasse 21, 4003 Basel, Switzerland

The Pharmacovigilance Quality Management System

This training course will describe contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System. The topics will cover organizational structure, responsibilities, processes and resources required for the pharmacovigilance (PV) system and its quality system.

Faculty

Brian  Edwards, DrMed

Brian Edwards, DrMed

Vice President, International Society of Pharmacovigilance, United Kingdom

After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, ISoP Board Member and VP in the Alliance Clinical Research Excellence and Safety (ACRES) . He chairs the unique Pharmaceutical ergonomics & human Factors Group in the UK. After 14 years at NDA Regulatory Science Ltd, he has his own pharmacovigilance consultancy Husoteria Ltd

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