This workshop is aimed at those 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. It may also be of interest to any QPPV who wish to refresh their knowledge.  Focus will be on the EU and new UK QPPV role, but will be relevant to other global QPPVs.  We will provide an overview to give you an understanding of QPPV roles, legal considerations for QPPVs and the practical issues facing QPPVs in a range of company sizes and types.

09:00 - 10:00 What does it mean to be a QPPV?
Elspeth McIntosh, Director, Castle Pharmacovigilance Limited, United Kingdom

10:00 - 10:40 Implementation and Organisation of the QPPV role in different types of companies
Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden
Elspeth McIntosh, Director, Castle Pharmacovigilance Limited, United Kingdom

10:40 - 11:00  Coffee Break

11:00 - 11:30 The QPPV role in Business Partner Management and Outsourcing
Elspeth McIntosh, Director, Castle Pharmacovigilance Limited, United Kingdom

11:30 - 12:00 The QPPV role in Quality oversight and Inspections
Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca, Sweden

12:00 - 12:30 QPPV Legal Issues
Anna Melin, Associate, Sidley Austin in Munich

12:30 - 13:00 Close out questions