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Session 6: Asia and Latin America Region Updates
Session Chair(s)
E. Stewart Geary, MD
MD, Global Safety Officer
Eisai Co., Ltd., Japan
The session will provide an update on new developments in pharmacovigilance and risk management in Latin America and Asia including Japan. The focus will be on providing a broad outline of PV regulations especially where they deviate from ICH standards and recent developments or changes in these countries.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand in broad outline the PV regulations in Asia (including Japan) and Latin America
- Learn of the most recent changes in regulations which affect risk management or pharmacovigilance in these countries
- Gain awareness of potential issues for PV compliance and country-specific expectations for the conduct of pharmacovigilance in those regions and how they can be addressed
Speaker(s)
Pharmacovigilance Update for Latin America
Fernando Pereira, RPH
Abbvie, Brazil
Director, Regional PV Lead Latin America (PACoE)
Pharmacovigilance Update for Japan and Asia
Mamiko Kasho
Eisai Co., Ltd., Japan
Executive Director, Global PV Management Dept., Global Safety HQs