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[Session 7] Development and Management of Strategic Labeling and Risk
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan
Labeling and Pharmacovigilance regulations are rapidly changing and various efforts have been made in the Asian region to adjust to these evolving requirements. Since simultaneous drug development based on MRCTs including the Asian region are increasing, efficient development of patient-centric labeling and risk management plans are clearly a priority. This session will share recent experience on these topics in Asia, and discuss current challenges and future perspectives on the management of labeling and risk management plans from the Asian and global points of view.
Speaker(s)
Shimon Yoshida, PHD
Executive Director, International Labeling Group, Global Regulatory Affairs, Pfizer Inc, United Kingdom
The End to End Labelling Process
Fengyun (Vicky) Han
Senior Director, Head of Regulatory Policy for Asia Pacific, Johnson & Johnson Pte. Ltd., Singapore
Labeling Management from Asia Regional Perspective
Gao Gao, MD
Director and Global Safety Risk Lead, Safety Surveillance and Risk Management, Pfizer China R&D Center, China
Risk Management Plan in Asia