The Role of the Qualified Person for Pharmacovigilance (QPPV)

This is a 3-day training programme which spans over three half-days.
Attending the full 3 days is mandatory.

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About this course

Fee: from € 250.00 per person

Speaker:

Sue Rees

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This course will examine the role of the Qualified Person for Pharmacovigilance (QPPV) and how to navigate the challenges

24 – 26 May 2022

12.00 pm – 15.00 pm (London, UK)

What you will learn:

  • History of the role and the EU Legislation
  • QPPV role in core PV Processes
  • The QPPV role in audit and inspection
  • How to be a successful QPPV
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Programme

Agenda

Day 1 – Tuesday 24th May

What is the QPPV?

  • History of the role and the EU Legislation
  • The PV System and the PSMF
  • Role of the QPPV in overcoming PSMF challenges
  • QPPV role in core PV Processes

Day 2 – Wednesday 25th May

Maintaining oversight of the PV system

  • Understanding the Quality Management System
  • Key elements of the Quality Management System
  • The QPPV role in audit planning and strategy
  • The QPPV role in inspections
  • Think global act local – interacting with affiliates and vendors
  • Who is in charge?
  • The role of  the global QPPV

Day 3 – Thursday 26th May

How to be a successful QPPV

  • How to be a successful QPPV
  • QPPV Office and the role of the deputy QPPV
  • Day in the life of a QPPV – navigating the challenges
  • Influence – the QPPV superpower
  • Characteristics of a good QPPV