Good Pharmacovigilance Practice Training
About This Course
Our course, complete with presentations, group discussions and case examples, promises to make pharmacovigilance colorful, dynamic, marvelous and interesting.
The aim of this interactive one-day course 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 course, 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
This course teaches you all you need to know about the latest EU requirements for pharmaceutical GMP.
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