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. It may also be of interest to any QPPV who wish to refresh their knowledge. The session will focus on providing an understanding of, and update on, the QPPV role, 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, United Kingdom
Magnus Ysander, EU QPPV & Head Pharmacovigilance Excellence, AstraZeneca
WORKSHOP AGENDA
12:45 - 13:00 – Log-in and connect
WORKSHOP AGENDA
13:00 - 13:45 - What does it mean to be a QPPV?
Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd
13:45-13:50 - Break
13:50-14:20 - QPPV Legal Issues
Anna Pavlou, Counsel, Sidley Austin LLP
14:20-14:40 - The 'Small Pharma' QPPV
Elspeth McIntosh, Director, Castle Pharmacovigilance Ltd
14:40-15:00 - Break
15:00-15:20 - QPPV oversight and the view from 'Big Pharma'
Magnus Ysander, EU QPPV and Head Risk Management & Pharmacovigilance Excellence, AstraZeneca
15:20-16:30 - Practical Issue for QPPVs: Presentations to highlight the QPPV role in:
· Business partner management and Outsourcing
· Quality oversight and processes and Inspection
· Pharmacovigilance System Master File (PSMF)
Elspeth McIntosh, Director, Castle Pharmacovigilance Limited
Magnus Ysander, EU QPPV and Head Risk Management & Pharmacovigilance Excellence, AstraZeneca
16:30 - 17:00 - Panel Discussion
Separate Registration Required
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