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Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation
Session Chair(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.
Learning Objective : Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.
Speaker(s)
Yoko Aoi, PHD
Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
PMDA Perspective
Romi Singh, PHD
Professor of Practice, Regulatory Sciences, Northeastern University, United States
Pharmaceutical Industry Perspective
Douglas Pratt
Supervisory Medical Officer, OVRR, CBER, FDA , United States
FDA Update
I-Chun Lai, MD, MS
Senior Director, Division of Consultation, Center for Drug Evaluation, Taiwan, Taiwan
Taiwan Perspective
Yangfeng Wu, MD, PHD
Executive Director, Peking University Clinical Research Institute, China
China Perspective
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