What you need to know about the new PharmacoVigilance Regulations

Online Training Id: GVP-002

Duration: 2 hrs

[Watch a Demo]

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

GBP $75.00