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[Session 2] Regulator’s Perspective for Drug Development Using Asia MRCT
Session Chair(s)
Yoshiko Komuro, PhD
Inspection Director, Office of Non-Clinical and Clinical Compliance
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Minsoo Park
KCGI, Korea, Republic of
NDAs based upon the results of MRCTs (multi-regional clinical trials) are steadily increasing. Drug development using Asian MRCTs is especially expected to be a pivotal strategy for global or Asian applications because of the high degree of similarity of ethnic factors within the region. Regulatory authorities have also released guidelines/notices to promote their respective country’s participation in MRCT and to use the clinical data from MRCT for regulatory applications. On the other hand, challenges in evaluating MRCT data remain. In this session, Asian regulators will share their review experiences of NDAs using such development strategies, and the current status surrounding MRCTs in Asia. Planning development strategies, review discussion matters, and future issues will also be discussed.
Speaker(s)
Regulator's Perspective for Drug Development using Asia MRCT (CDE, CFDE)
Siyuan Qian
CDE, CFDA, China
Senior Reviewer, Associate Chief Pharmacist, Office of Clinical Evaluation II
Regulatory Perspectives of Asian MRCT (T-CDE)
I-Chun Lai, MD, MS
Center for Drug Evaluation, Taiwan
Director, Consultation Division
Regulatory Management of NDA and MRCT in Korea
Nam Soo Kim
Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Deputy Director, Biopharmaceutical Policy Division
Review Experiences of Multi Regional Clinical Trials (MRCTs) (Asian Trials)
Naoto Kato
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of New Drug III / International Senior Training Coordinator
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