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Session 10: Emerging Regions Issues
Session Chair(s)
E. Stewart Geary, MD
Senior Vice President
Eisai Co., Ltd., Japan
As China has joined the ICH community it has leaped ahead in published requirements for electronic reporting (E2B(R3)) during clinical trials and requests for Risk Management Plans sometimes without detailed guidance or the infrastructure for clinical trial sponsors and marketing authorization holders to be confident in their path to compliance. The current, rapidly evolving situation in China for these requirements will be presented along with suggestions on how industry can meet the expectations of the Chinese regulatory authorities. Since the adoption of the Pharmacovigilance System Master File in the EU, a number of non-EU countries have indicated interest in adopting formal or informal requirements for a local PSMF. A presentation will be given on how a coordinated approach to generating and maintaining a PSMF for regulators outside the EU
Learning Objective : Upon completion of this session, the participant should be able to:- Prepare for compliance with new Pharmacovigilance regulations in China
- Implement strategies for global management of PSMF’s (no's)including for countries outside the EU
- Describe different practical approaches to PSMF management
Speaker(s)
The Adventures of the Pharmacovigilance System Master File Outside the European Union
Dionne Usher
Merck Sharp & Dohme Limited, United Kingdom
Associate Director, Office of the EU QPPV
Updates of China Regulatory and Pharmacovigilance Environment
Han Ma
Roche, China
Asia Pacific Site Head
PSMF – A Global Perspective
Naomi Morris, MS
Pfizer Srl., Italy
Head of QPPV Compliance Office
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