DIA 48th Annual Meeting
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Streamlining of Clinical Trial Review Process in Asian Pacific Region
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
162
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Chih-Hwa Wallace Lin, Center for Drug Evaluation, Taiwan
PRESENTER
(S):
Chien-Liang Lin, Food and Drug Administration, Department of Health, Taiwan Shun Jin, Takeda Global Research & Development Center, Inc., Singapore Neil McAuslane, Centre For Innovation In Regulatory Science (CIRS), United Kingdom
Description
With global development, Asian regulatory agencies are streamlining the clinical trial process. Taiwan is adapting the Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) system. Korea and Japan have enhanced the review of the clinical trial. This session will discuss revolutionary measures and impacts.
Learning Objectives:
Describe the recent revolutionary measures of streamlining the clinical trial review process in the Asian Pacific region
Compare the various models in Asian Pacific region among Asian countries such as Taiwan, Korea, and Japan
Discuss the impact on regulatory affairs/new drug development in the Asian Pacific region.
Learning Objectives:
Describe the recent revolutionary measures of streamlining the clinical trial review process in the Asian Pacific region
Compare the various models in Asian Pacific region among Asian countries such as Taiwan, Korea, and Japan
Discuss the impact on regulatory affairs/new drug development in the Asian Pacific region.
This session is a part of:
Handout Online
