11th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 11th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants.

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Session 7: Change Management in line with Pharmacovigilance System Updates

Session Chair(s)

Margaret Anne Walters

Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd, United Kingdom

In November this year the EMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in line with the revised EU Pharmacovigilance legislation. This session will provide updates from several key EMA implementation leads together with an example of an MAHs planning for change. This will be followed by a panel discussion with key EMA speakers towards better enabling effective QPPV oversight of timely and effective internal implementation. Specific topics will include challenges for reporting (including ICSR downloads), processes for MAH signaling in EV and related access policy/data privacy questions.

Speaker(s)

Francois Domergue

EV Auditable Requirement Project Manager, Business Data and Analytics Department, European Medicines Agency, Netherlands

Nick Halsey

Scientific Administrator, European Medicines Agency, Netherlands

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