How to survive a PharmacoVigilance regulatory Inspection
Online Training Id: GVP-003
Geographical Region: Global
Level: Intermediate
Duration: 1 hr 30 mins
This course gives an overview about the legal background of a Pharmacovigilance Inspection, the preparation of the company in the forefront of the inspection (“inspection readiness”) and the procedure of the inspection by the Regularity authority.
Learning Objectives:
The presenter will highlight the more common issues of noncompliance in PHV regulations and will detail the actions necessary to prepare for a GVP.
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
