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