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Session 8 - Labeling in Asia
Session Chair(s)
Rie Matsui, RPH
Senior Director, Regional Labeling Head for APAC
Pfizer R&D Japan G.K., Japan
Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the headquarters organization while local healthcare professional information and patient leaflets are handled by staff based in local offices. This session will provide a case study discussion on the implementation of a regional hub model for Asia. The session will also explain labeling requirements for countries in Asia such as Japan, China, and Korea. In addition, PMDA will answer the frequently asked questions on unique Japanese regulations for labeling and practices in Japan. This information is particularly relevant for Western companies attempting to implement Core Safety Information in Japan.
Speaker(s)
Implementation of an Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View
Rie Matsui, RPH
Pfizer R&D Japan G.K., Japan
Senior Director, Regional Labeling Head for APAC
Q&A: Japanese Labeling Requirements
Takashi Misu, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Coordinator, Office of International Strategy and Planning