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 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.

AGENDA

09:00-10:00 - What does it mean to be a QPPV?

                      Elspeth McIntosh,Director, Castle Pharmacovigilance Ltd

10:00-10:45 - Implementation and Organisation of the QPPV role in different types of companies

                       Magnus Ysander, EU QPPV and Head Pharmacovigilance Excellence, AstraZeneca

                       Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd

10:45-11:10 - Coffee Break

11:10-11:45 - The QPPV role in Business Partner Management and Outsourcing

                       Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd

11:45-12:20 - The QPPV role in Quality oversight and Inspections

                      Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca

12:20-12:50 - QPPV Legal Issues

                      Anna Melin, Associate, Sidley Austin, Munich

12:50-13:30 - Questions