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Session 7: EU/ex-EU QPPV Interactions and Challenges
Session Chair(s)
Shahinaz Badr
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Pharma Quality Europe, 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)
UK QPPV: Brexit Updates
Elspeth McIntosh, MBA, RN
Castle Pharmacovigilance Ltd, United Kingdom
Director
Proliferation of QPPVs: what you need to know? - Middle East QPPV
Shahinaz Badr
Pharma Quality Europe, United Arab Emirates
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Proliferation of QPPVs: what you need to know? - Euroasia QPPV
Olga Ermishina, MD
Bayer, Russian Federation
Pharmacovigilance Country Head, Qualified Person for Pharmacovigilance in EAEU
Proliferation of QPPVs: what you need to know? - Interfaces with EU QPPVs
Gabrielle Amselem, PharmD
Alexion, AstraZeneca Rare Disease, France
Dir, Pharmacovigilance Excellence Expert
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