Session-2-Hot-Topics-for-QPPV-Oversight

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 2 Hot Topics for QPPV Oversight

Session Chair(s)

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV

Abbvie, United Kingdom

Post the new legislation implementation we are still in a time of change whereby new GVPs and guidance documents are released and existing documents are updated. The industry continues to engage with the Regulators to provide feedback on the changes and new requirements on practical implications and opportunities for clarifications and potential improvements. Not all companies are represented on the various trade associations that form the main forum for ongoing discussion with Regulators and so this session will share the topics of interest currently under discussion. Topics of interest that the EFPIA and other industry trade associations are actively discussing with the Regulators for example PSPs, Off-label use, PASS and PAES, signal detection Speakers will be from the working groups engaged in specific topics New issues and progress of ongoing issues will be presented

Speaker(s)

Brexit

Vicki Edwards, RPh

Abbvie, United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

Medical Literature Monitoring

John Barber

Dr. Reddy's Laboratories (UK) Ltd., United Kingdom

QPPV and Director, Head of Pharmacovigilance, European Operations

Reference Safety Information

Esteban Herrero-Martinez, PhD

AbbVie, United Kingdom

Director Regulatory Policy and Intelligence

Module V

Guy Demol

MSD, Belgium

EU QPPV

Off-label Use

Michael Richardson, MD, FFPM, FRCP

Bristol-Myers Squibb, United Kingdom

Senior Vice President, WorldWide Patient Safety

Module IX

Kristina Strutt, MD, MA, MRCP, FFPM

Ipsen Biopharm Limited, United Kingdom

Senior Vice President

Biologics

Sue Rees, MS

Sue Rees Consultancy Ltd, United Kingdom

Director

Module VI

Peter De Veene, MD

MSD Belgium, Belgium

GQPPV

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10th Annual Forum for Qualified Persons in Pharmacovigilance

Session 2 Hot Topics for QPPV Oversight

Session Chair(s)

Vicki Edwards, RPh

Speaker(s)

Brexit

Medical Literature Monitoring

Reference Safety Information

Module V

Off-label Use

Module IX

Biologics

Module VI

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