10th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 10th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants of the past nine meetings. There is an enhanced opportunity for networking as the lectures are followed by a dinner.

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Session 1 Key Notes

Session Chair(s)

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety

Bristol-Myers Squibb, United Kingdom

The EU PV legislation, which came with clearly defined objectives, has been in force since 2012. Additional to this PRAC and the EMA have clarified and evolved multiple projects. This session will ask key regulators and Industry the following questions: Have the deliverables of transparency, simplification and enhanced evaluation of benefit risk been achieved? Are the regulators gaining better oversight and insight to the use of medicines within Europe and have Patients and Healthcare providers received better and clearer information on the products they use? Are industry and regulators better able to collaborate and communicate in the oversight of the use of medicines and does the QPPV have greater oversight of the safety of the products for which they have responsibility? How is the global environment requiring a single point oversight of the system changing the QP role organisationally to maintain consistent safety oversight?

Speaker(s)

Key Note - Regulator

Peter Richard Arlett, MD, FFPM, FRCP

European Medicines Agency, Netherlands

Head Data Analytics and Methods Task Force

Key Note - Industry

Danie du Plessis

GSK, United Kingdom

SVP and Head Worldwide Medical Affairs

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