Overview
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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