Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to ask

EU legislation requires all marketing authorisation holders to have a qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of a marketing authorisation holder’s (MAH’s) pharmacovigilance system in the EU, as well as this system’s interfaces with other regions of the world. The responsibilities of the QPPV apply wherever there is an active MA for a product authorised in the EU/EEA. Thus the role in many companies has a global impact. During this tutorial we will discuss and advise on current practice to help address these and other issues

• Qualified person for pharmacovigilance
• Deputy Qualified persons for pharmacovigilance
• Heads of pharmacovigilance or Drug Safety
• Pharmacovigilance auditors and inspectors
• Head of Regulatory Affairs
  

At the conclusion of this tutorial, attendees will be able to:

• Explain legal, regulatory and business implications of the QPPV function 
• Describe the expectations of different stakeholders  
• Understand the different approaches taken by various companies  
• Gain better insight into the evolving requirements of regulators and inspectors