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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
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)
Future of Clinical Development Strategy in Taiwan after ICH E17 Guideline Implementation - the Perspective of a Regulator
Lih-Jiuan Hsu
Center for Drug Evaluation, Taiwan, Taiwan
Deputy Executive Director
Review Experiences of Multi Regional Clinical Trials (MRCTs)(Asian Trials)
Katsuhiko Ichimaru
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of New Drug IV
How ICH E17 Affects Clinical Trials in Asia
Koichi Miyazaki, PhD
Daiichi Sankyo Co., Ltd., Japan
Senior Director, Group IV, Oncology Clinical Development Department