DIA 48th Annual Meeting
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Pharmacovigilance in Japan and Risk Management Plans
Track : Track 14: Clinical Safety and Pharmacovigilance
Program Code: 233
Date: Tuesday, June 26, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Stewart Geary, Eisai Co., Ltd., Japan
PRESENTER (S):
 Tatsuo Kurokawa, Keio University, Japan
Yorozu Tabata, PRTM, Japan
 Kazuhiko Mori, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Description
This symposium will provide an update on the latest developments in pharmacovigilance in Japan with speakers from the regulatory authority and the pharmaceutical industry based in Japan. Discussions will provide both an overall description of the current system of drug safety regulation, as well as recently implemented changes and the prospects for further developments in drug safety regulation in Japan.

Learning Objectives:
Identify the latest developments in pharmacovigilance in Japan
Describe the status of Risk Management Plans and the DSUR in Japan
Recognize your ability to anticipate the Pharmacovigilance needs of your partners in Japan.