JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 16
Type: Topic Contributed
Date/Time: Sunday, July 29, 2007 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract - #309453
Title: Issues in Conducting Multiregional Trial: Experience in the PMDA Consultation Meetings
Author(s): Yuki Ando*+
Companies: Pharmaceuticals and Medical Devices Agency
Address: 3 3 2 Kasumigaseki Chiyodaku, Tokyo, 100-0013, Japan
Keywords: multi-regional trial ; simultaneous drug development
Abstract:

Recently an increasing number of Japanese pharmaceutical companies have planned to participate in multi-regional trials, in order to reach the goal of global simultaneous drug development and nearly simultaneous world-wide registration. Although it is desirable for such trials to be conducted under a common protocol among the participating regions, there may be a need to allow minor regional design differences e.g., concomitant medication. In this presentation, recent issues raised in PMDA consultation meetings that focused on global simultaneous drug development programs will be reviewed with a few examples in which regional protocol differences were needed.

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Revised September, 2007