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Session 2: Regulatory Updates on Polices and New Guidances from Other Territories and International Harmonization
Session Chair(s)
Mamiko Kasho
Executive Director, Global PV Management Dept., Global Safety HQs
Eisai Co., Ltd., Japan
The session will provide updates on pharmacovigilance and risk management in countries of Asia region and how we comply with local specific requirements in those rapidly evolving environments. The focus this year will be describing pharmacovigilance requirements in India, some updates in China and Japan, and comparison of Pharmacovigilance System Master File requirements in Asia.
Learning Objective : - Understand the overview of regulatory requirements for drug safety in the Middle East and African countries and key challenges
- Recognize the high-level overview of TransCelerate PV initiatives update and global harmonization activities
Speaker(s)
Speaker
Mamiko Kasho
Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs
Speaker
Andrew Bate, PhD, MA
GlaxoSmithKline, United Kingdom
Vice President, Head of Safety Innovation and Analytics