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 6: EU QPPV Oversight Outside of the EU

Session Chair(s)

Barbara De Bernardi, MD

EUQPPV Vice President - Head of Global QPPV Office, Pfizer S.r.l., Italy

Pharmacovigilance has evolved significantly over the past ten years in the EU, where the EU QPPV has a key role in the oversight of PV system for all medicinal products for which the company holds marketing authorisations. The adoption of principles similar to those in the EU PV legislation is increasing in a significant number of ex-EU countries and regions (e.g. Arab league, EAEU league, Ukraine, Israel, Turkey, Cambodia, Malaysia, Ghana, Nigeria, Kenya, etc). The availability of a Pharmacovigilance Responsible Person is now mandatory in many of them in order to ensure PV system compliance. This increasing complexity of regulatory requirements across the regions needs intense interactions between EUQPPV, ex-EUQPPVs and Local PV contacts. Therefore, should the EUQPPV role be « globalized » to play the additional business critical role of“ company PV policy holder” ? This session will provide updates on current regulatory and industry scenarios.

Speaker(s)

Pharmacovigilance in the Rest of the World

Director Regulatory Policy and Intelligence, Novartis Pharmaceuticals UK Limited, United Kingdom

Willemijn van der Spuij, MSC

Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland

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