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Session 3 / Venue 3: Implementation of and Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
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 health care professional information and patient leaflets are handled by staff based in local offices. This session will provide an overview of how global labeling systems handle implementation of CCDS information in the US-PI and EU-SmPC, as well as a case study discussion on the implementation of a regional hub model for Asia. Consideration of differences in practice across countries and companies, as well as the prospects for future initiatives around labeling such as a harmonization will be discussed. The session will also offer a perspective on how the industry is managing the integration and alignment of global safety and labeling systems and governance to ensure end-to-end oversight and implementation of patient safety information.
Speaker(s)
Implementation of Global Safety Labeling in US and EU Countries
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
[V3-S3] 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, International Labeling
Reiko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Director, Office of Safety II
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