How to survive a PharmacoVigilance regulatory Inspection
Online Training Id: GVP-003
Geographical Region: Global
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.
The presenter will highlight the more common issues of noncompliance in PHV regulations and will detail the actions necessary to prepare for a GVP.
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