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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, Regulatory Science Center, 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)
Yoshiaki Uyama, PhD, MS, RPh
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overview of ICH E17
I-Chun Lai, MD, MS
Senior Director, Division of Consultation, Center for Drug Evaluation, Taiwan, Taiwan
T-CDE’s Experiences to Review MRCT Results and Expectations for E17 Guideline
Mee Ryung Ahn, PhD
Director, Ministry of Food and Drug Safety, Korea, Republic of
MFDS’s Experiences to Review MRCT Data
Yoko Aoi, PhD
Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA’s Experiences to Review MRCT Results and Expectations for E17 Guideline
Osamu Komiyama
CEO, Office Komiyama, Japan
Yasuto Otsubo
Review Director, Office of New Drug II , Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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