Back to Agenda
Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation
Session Chair(s)
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
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)
PMDA Perspective
Yoko Aoi, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug V
Pharmaceutical Industry Perspective
Romi Singh, PhD
GRA Advisors, United States
Founder & Principal Advisor
FDA Update
Douglas Pratt
FDA , United States
Supervisory Medical Officer, OVRR, CBER
Taiwan Perspective
I-Chun Lai, MD, MS
Center for Drug Evaluation, Taiwan
Director, Consultation Division
China Perspective
Yangfeng Wu, MD, PhD
Peking University Clinical Research Institute, China
Executive Director
Have an account?