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#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies

Nov 6 2013 9:00AM - Nov 6 2013 10:45AM | TFT Halls & Rooms TFT Building, 3-6-11 Ariake, Koto-ku, Tokyo 135-8071 Japan

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Session Chair
Rie Matsui, RPh
Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR-International and Global Product Information, Pfizer Japan Inc.

Global companies have developed Company Core Data Sheet (CCDS), and the number of Japanese label revisions based on CCDSs has increased. In most global companies, the CCDSs have been developed in Western headquarters. This tutorial will focus on how the safety content of CCDSs is generated and, in particular, on how to select ADRs and ADR frequency information is selected for inclusion in CCDS and for global implementation. It will be explained how the interpretation of the rules for writing adverse reaction section the US PI and the EU SmPC influences the content of CCDSs, and why some interpretations lead to information in CCDSs that cannot be implemented in other countries without major deviations. Particular problems with the implementation of some types of information in the Japanese PI are discussed. The tutorial also presents a “truly global” approach to selecting ADRs for CCDSs so that consistent global submissions are possible.

A. Leander Fontaine, Dr. med.
President, Pharmiceutics, LLC

Contact Information 

DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200


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