DIA 48th Annual Meeting
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Regulatory Handling of Ethnic Factors in Asian Clinical Trial Data #3, Implication for Simultaneous Global Development (SGD)
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
421
Date:
Thursday, June 28, 2012
Time:
10:45 AM to 12:15 PM
EST
CHAIR
:
Akio Uemura, Allergan Japan K.K., Japan
PRESENTER
(S):
Yoshiaki Uyama, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Michael Rozycki, Allergan, Inc., China Yoshihiko Ono, Pfizer Japan Inc, Japan
Description
Countries in Asia are increasing requirements for clinical data generated in their own region. In this session, we will outline expectations for handling ethnic factors by both regulators and the industry, and discuss possible future regulations.
Learning Objectives:
Discuss different regulators' expectations for handling ethnic differences in multiregional clinical trials for registration
Discuss actual case studies by companies who experienced SGD including Asian regions
Describe future international regulations for handling ethnic factors in SGD.
Learning Objectives:
Discuss different regulators' expectations for handling ethnic differences in multiregional clinical trials for registration
Discuss actual case studies by companies who experienced SGD including Asian regions
Describe future international regulations for handling ethnic factors in SGD.
This session is a part of:
Handout Online
