Introduction to the role of QPPVs

Overview

As a result of feedback from previous years we are repeating this workshop aimed at those EU QPPVs who are new to the role, need to refresh on the role, those who support the QPPV and those who are thinking of taking on a QPPV role. The session will focus on providing an understanding of and update on the QPPV role and the support required, the practical issues facing QPPVs in a range of company sizes and types, legal considerations for QPPVs and expectations of the QPPV in audit and inspection.

Featured topics

Workshop Chair:
Elspeth McIntosh, Director, Castle Pharmacovigilance Limited, UK

12:00 Registration and coffee

13:00 What does it mean to be a QPPV?
Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd, UK

QPPV Legal Issues
Chris Foreman, Senior Director, Legal Affairs, Nordic Region, Merck Sharp & Dohme (Europe) Inc., Belgium

QPPV Challenges - Panel Discussion

Session speakers

Margaret Walters, Director & Deputy EU Qualified Person for Pharmacovigilance, Merck Sharp & Dohme Ltd., UK

15:15 Refreshment Break

QPPV Backup and Required Skills/Training:
Large Company Perspective: Maria Wishart, Deputy QPPV, AstraZeneca, UK & Magnus Ysander, QPPV, AstraZeneca, Sweden
Small Company Perspective: Jefferson Guillon, Pharmacovigilance Manager & EEA QPPV, Alliance Pharmaceuticals Ltd, UK

QPPV and QA/Audit/Inspection
Janet Scott, Senior Consultant (Pharmacovigilance), Xendo, UK

Panel Discussion

Session speakers

Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd, UK
Margaret Walters, Deputy EU Qualified Person for Pharmacovigilance, Merck Sharp & Dohme Ltd., UK
Michael Richardson, International Head of GPV&E and EU QPPV, Bristol-Myers Squibb Pharmaceuticals Ltd., UK
Peter De Veene, Head Global Drug Safety & QPPV, Grünenthal

Separate registration required

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Introduction to the role of QPPVs

Overview

Featured topics

Be informed and stay engaged.