Pharmacovigilance and Risk Management Strategies Conference
Session 1: Asia Region Updates
Session Chair(s)
E. Stewart Geary, MD
- Senior VP, Global Safety Officer, Director, Corporate Medical Affairs HQ
- 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
- Managing Director and CEO
- Oviya MedSafe, India
New Japanese Package Insert Format and Overview of Labeling in Asia
Rie Matsui, RPh
- Senior Director, Regional Labeling Head for APAC
- Pfizer R&D, Japan
E2B (R3) Implementation for Pharmacovigilance Reporting in China
Stella Xu
- Senior Manager, Drug Safety and Pharmacovigilance
- dMed, China
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Pharmacovigilance and Risk Management Planning
Short Course 2: Interdisciplinary Safety Evaluation During Product Development
Short Course 3: Reference Safety Information
Short Course 4: Introduction to Statistics in Pharmacovigilance
Short Course 5: Pharmacovigilance for Medication Errors
On Demand Content Preview Webinar
Preparing for PV Inspections – Beyond the Basics
Download eBook
Pharmacovigilance and Risk Management in 2020: A Global Perspective