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Session 1: Asia Region Updates
Session Chair(s)
E. Stewart Geary, MD
Senior Vice President
Eisai Co., Ltd., Japan
The session will provide an update on pharmacovigilance in India including the structure of the pharmacovigilance system and key regulations which clinical trial sponsors and marketing authorization holders must follow for compliance. A review of the new format for the Japanese package insert, with an emphasis on the presentation of safety information, along with the timelines and considerations for implementation will be described as well as an overall update on labeling in Asia. The new requirement for E2B (R3) reporting implementation in China for clinical trials as well as plans for post-marketing reporting will be explained as well as key issues to address in system implementation and vendor selection.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe current conditions and requirements for pharmacovigilance in India
- Understand the issues which need to be addressed when planning E2B (R3) implementation in China
- Anticipate the coming change in package insert format in Japan and its timeline for implementation as well as current movements for labeling in Asia
Speaker(s)
Post-Approval Pharmacovigilance Obligations for the Industry in India: Current Scenario
J Vijay Venkatraman, MD, MBA
Oviya MedSafe, India
Managing Director and CEO
New Japanese Package Insert Format and Overview of Labeling in Asia
Rie Matsui, RPh
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC, International Labeling
E2B (R3) Implementation for Pharmacovigilance Reporting in China
Stella Xu
dMed, China
Senior Manager, Drug Safety and Pharmacovigilance