How to survive a PharmacoVigilance regulatory Inspection

Online Training Id: GVP-003

Geographical Region: Global

Level: Intermediate

Duration: 1 hr 30 mins

[Watch a Demo]

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

GBP $75.00