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Session 2: Drug Development Using Asia Multi-Regional Clinical Trials (Part 1)
Session Chair(s)
Koichi Miyazaki, PhD
Senior Director, Group IV, Oncology Clinical Development Department
Daiichi Sankyo Co., Ltd., Japan
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Our goal is to bring innovative new drugs to patients as soon as possible through thoughtful and efficient drug development. To achieve the purpose, multi-regional clinical trials (MRCT) is now widely recognized as an optimal and efficient drug development pathway by avoiding duplicative works. In fact, regulatory authorities have undertaken many important initiatives and released guidelines/notices to promote their countries to participate in MRCT and to use the clinical data from MRCT for regulatory application. Among them, Asia MRCT is especially expected to be a pivotal strategy for the regulatory application in the region because of ethnic similarity. On the other hands, some challenges in evaluating data from MRCTs still remain. In this session, speakers from health authorities and pharmaceutical companies will address current status and future prospects of MRCT to help you to explore these increasingly important issues.
Speaker(s)
Regulatory Trends of MRCT (TCDE)
Gau Churn-Shiouh, DrSc
Project Office of Sustainable Platform For Big Data In Health By MOHW, Ching-Kan, Taiwan
Office Director
Regulatory Trends of MRCT (MFDS)
Sun-young Kim, MS
Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Assistant Director, Clinical Trials Management Div, Pharmaceutical Safety Bureau
Regulatory Trends of MRCT (PMDA)
Akihiro Ishiguro, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug III
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