About This Workshop

Our face-to-face workshop, complete with presentations, group discussions and case examples, promises to make pharmacovigilance colorful, dynamic, marvelous and interesting.

The aim of this interactive one-day workshop is to provide an introduction to Good Pharmacovigilance Practice (GVP) for those at the Good Manufacturing Practice (GMP)/GVP interface. This includes those managing product quality complaints, supply/distribution chains and GMP quality systems. We also explore the contrasting role of the Qualified Person (QP) for pharmacovigilance.

Key Learning Objectives

By the end of this workshop, you will:

  • Be able to outline the key principles of GVP and have an overview of key European GVP legislation and guidance
  • Understand the links between the pharmacovigilance and GMP systems in a company
  • Have evaluated a typical pharmacovigilance system and be able to describe at least three aspects where GMP and GVP systems have critical interfaces
  • Have an awareness of, and have received information on, hot topics including electronic records, data integrity and the role of the QP for pharmacovigilance
  • Have discussed and received information on common GVP inspection findings

Who Should Attend

  • Affiliate/country organizations’ quality assurance (QA) and pharmacovigilance staff
  • GMP auditors, QPs and technical specialists (responsible for the management of product quality complaints and/or distributors)
  • GVP and GMP managers wishing to gain an understanding of this Good Practice (GxP) interface and current regulatory hot topics