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Overview

Limited Places Available

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.

WORKSHOP INSTRUCTORS

Elspeth McIntosh, Director, Castle Pharmacovigilance Limited
Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca
Anna Melin, Associate, Sidley Austin

WORKSHOP AGENDA

12:45 - 13:00 - Log-in and Connect

13:00 - 13:50 - What does it mean to be a QPPV?
                         Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd

13:50-14:20 - QPPV Legal Issues
                       Anna Melin, Associate, Sidley Austin

14:20-14:40 - Coffee Break

Practical Issue for QPPVs - Presentations to Highlight:

14:40-15:10 - Implementation and Organisation of the QPPV role in different types of companies

15:10-15:40 - The QPPV role in the Pharmacovigilance System Master File

15:40-15:50 - Coffee Break

15:50-16:20 - The QPPV role in Business Partner Management and Outsourcing

16:20-16:50 - The QPPV role in Quality oversight and Inspections 
                       Elspeth McIntosh, Director, Castle Pharmacovigilance Limited
                       Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca

16:50 - 17:00 - Closing Questions

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+41 61 225 51 51