What you need to know about the new PharmacoVigilance Regulations
Online Training Id: GVP-002
Duration: 2 hrs
This course gives an overview about the legal background of Pharmacovigilance regulation, and will review the new regulations for Good Vigilance Practice, the PharmacoVigilance System, Master file, and the duties & responsibilities of the Qualified person.
Learning Objectives:
The presenter will review the NEW regulations relevant to Pharmacovigilance systems in Europe and the actions necessary to prepare the Pharmacovigilance System Master File (PSMF).
Author:
ChemistFormer Direktor and Professor at Federal Institute for Drugs and Medical DevicesHead of Unit Risk Management Procedures and Pharmacovigilance Inspections Since 1981- Employee at Institute of Drugs of the Federal Health Authority / Federal Institute for Drugs and Medical Devices at the Department Post Marketing Surveillance / Pharmacovigilance Since 1986 - Head of Unit Risk Management Procedures, Pharmacovigilance Inspections since 2014 - Consultant Senior Expert Pharmacovigilance
Dr. Axel Thiele
PHARMACOVIGILANCE COMPLIANCE AUDITING
