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Session 7: EU/ex-EU QPPV Interactions and Challenges
Session Chair(s)
Shahinaz Badr, PHARMD
Founder & Managing Director, Vigilance Gate FZ,LLC, United Arab Emirates
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
As more territories adopt a QPPV role based on the EU responsibilities, EU QPPVs need to know how these local requirements are being implemented and how this effects the EU functions. By looking at the requirements for a couple of the more established ex-EU QPPV roles, we will describe some of the ways that EU QPPVs can influence, support and interact with their other colleagues, and introduce some of the local challenges which can, and do, have an impact on the EU PV systems and data.
Speaker(s)
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
UK QPPV: Brexit Updates
Shahinaz Badr, PHARMD
Founder & Managing Director, Vigilance Gate FZ,LLC, United Arab Emirates
Proliferation of QPPVs: what you need to know? - Middle East QPPV
Olga Ermishina, MD
Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU, Bayer, Russian Federation
Proliferation of QPPVs: what you need to know? - Euroasia QPPV
Gabrielle Amselem, PHARMD
Dir, Pharmacovigilance Excellence Expert, Alexion, AstraZeneca Rare Disease, France
Proliferation of QPPVs: what you need to know? - Interfaces with EU QPPVs
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