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[Session 2] Regulatory and Industry Challenges to ICH E17 Implementation
Session Chair(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
At the November 2017 ICH Geneva meeting, the ICH E17 guideline “General Principles for Planning and Design of Multi-Regional Clinical Trials (MRCTs)” was finalized. Promoting multiregional drug development increases the number of regions participating in a MRCT; regional regulatory authorities and industry are being expected to challenge in consistency evaluation between overall and regional results, and sample size allocations to regions. In this session, several regulatory authorities will provide their perspective on current difficulties with not only planning and designing MRCTs but also data interpretation and challenges from implementing this guideline. Panel discussion will exchange various opinions from regulatory authorities and additional industry panelists.
Speaker(s)
Overview of ICH E17
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
T-CDE’s Experiences to Review MRCT Results and Expectations for E17 Guideline
I-Chun Lai, MD, MS
Center for Drug Evaluation, Taiwan, Taiwan
Senior Director, Division of Consultation
MFDS’s Experiences to Review MRCT Data
Mee Ryung Ahn, PHD
Ministry of Food and Drug Safety, Korea, Republic of
Director
PMDA’s Experiences to Review MRCT Results and Expectations for E17 Guideline
Yoko Aoi, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Coordination Director - Office of Review Management
Osamu Komiyama
Pfizer R&D Japan G.K., Japan
Senior Manager, Statistical Research & Data Science
Yasuto Otsubo
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of New Drug II