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[V1-S2] Future of Clinical Development Strategy in Asia after ICH E17 Guideline Implementation
Session Chair(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
The ICH-E17 guideline “General principle on planning/designing Multi- Regional Clinical Trials” is currently under consideration. Regulators from Asia will present the harmonized guideline, focusing on implementation in their own countries, changes in the drug development strategy, and assumed challenges in guideline implementation.
Speaker(s)
Lih-Jiuan Hsu
Deputy Executive Director, Center for Drug Evaluation, Taiwan, Taiwan
Future of Clinical Development Strategy in Taiwan after ICH E17 Guideline Implementation - the Perspective of a Regulator
Katsuhiko Ichimaru
Review Director, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Experiences of Multi Regional Clinical Trials (MRCTs)(Asian Trials)
Koichi Miyazaki, PHD
Senior Director, Group IV, Oncology Clinical Development Department, Daiichi Sankyo Co., Ltd., Japan
How ICH E17 Affects Clinical Trials in Asia
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