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Session 6: OPERATING AS A QPPV IN DIFFERENT COMPANIES
Session Chair(s)
Natalia Kocankova, MD, MBA
Strategic Advisor/Office Director
Primevigilance s.r.o., Czech Republic
The scope of the role of EU QPPV is clearly defined in the EU legislation. In this session you will have the opportunity to learn how roles and priorities of EU QPPVs may differ in different types of companies and different cultural environments. The session will convey practical experience of EU QPPVs providing services for contract and small companies; you will learn what the daily challenges for EU QPPVs from generics companies are, and you will get an overview of the role of EU QPPV focusing on cultural differences.
Speaker(s)
Kees Bart Teeuw, PhD
Astellas Pharma Europe, Netherlands
Vice President Drug Safety & Pharmacovigilance
Contract and Small Company QPPVs
Elspeth McIntosh, MBA, RN
Castle Pharmacovigilance Ltd, United Kingdom
Director
Generics – Challenges in meeting requirements for: RMPs, PASS, CCSI, Product transfers & Mergers
Balwant Heer
Mylan Inc., United Kingdom
VP, Global Head Product Safety & Risk Management, EEA QPPV
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