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ASIA: CREATING POSSIBILITIES FOR CLINICAL DEVELOPMENT AND COLLABORATION
Session Chair(s)
Toshiyoshi Tominaga, PhD
Project Professor
Keio University Hospital, Japan
Regional Heterogeneity in Multi-Regional Clinical Trials - Experiences with regional health authorities
Learning Objective : This session will describe the common phenomenon that different treatment effects are observed for different regions in a multi-regional clinical trial. Participants will have a better understanding of the issue and learn to interpret data appropriately and put them into context. They will also hear about experiences that how regional health authorities handle the matter.
Speaker(s)
Regulatory Perspective to Review MRCT Data for Drug Approval: Focusing on ethnic factor evaluation
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Efforts of MFDS for Facilitating Access to Medicines
Hojeong Kim
MFDS, Korea, Republic of
Director NIFDS
Regional Heterogeneity in Multi-Regional Clinical Trials - Experiences with regional health authorities
Jane Xu
Sunovion Pharmaceuticals, Inc., United States
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