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Session 5: Excellence of Labeling Management in Asia
Session Chair(s)
E. Stewart Geary, MD
MD, Global Safety Officer
Eisai Co., Ltd., Japan
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
Labeling is an important risk minimization measure in the risk management plan. Local labeling management is always challenging for multinational companies. Since labeling harmonization has not yet been established in across Asian countries as is done in the EU, we must prepare and revise for labels creation based on the regulations in each country. Labeling compliance is becoming increasingly more important. In this session, we will present an overview of labeling regulations in Asia, labeling preparations for new drugs, actual practices for label revisions of safety information and how we should handle and manage label revisions in the Asia region, in accordance with company policies while following local regulations. In addition, we will share how to measure labeling compliance and current challenges. Furthermore, future prospects for labeling in Asia will be discussed.
Speaker(s)
Global Labeling Management
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
MD, Global Safety Officer
Labeling Regulations and Regional Best Practices for Labeling Process in Asia
Rie Matsui, RPh
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC, International Labeling
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