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Wednesday, June 19 • 4:30pm - 5:30pm
#374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Yoshiaki Uyama, PhD, RPh

Speaker

PMDA Perspective
Yoko Aoi, PhD

Pharmaceutical Industry Perspective
Romi Singh, PhD

FDA Update
Douglas D. Pratt

Taiwan Perspective
I-Chun Lai, MD, MS

China Perspective
Yangfeng Wu, MD, PhD


Speakers
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for Yoko Aoi

Yoko Aoi

Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
avatar for I-Chun Lai

I-Chun Lai

Director, Consultation Division, Center for Drug Evaluation, Taiwan
Dr. I-Chun Lai graduated with her medical degree from Taipei Medical University in Taiwan in 2001 and worked as a physician until 2007, when she joined the Center for Drug Evaluation (CDE) in Taiwan. In 2013, she received her Master of Science from the Institute of Health Policy and... Read More →
DP

Douglas Pratt

Supervisory Medical Officer, OVRR, CBER, FDA , United States
avatar for Romi Singh

Romi Singh

Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
YW

Yangfeng Wu

Executive Director, Peking University Clinical Research Institute, China
Professor Wu is the Executive Director of Peking University Clinical Research Institute. He has been principal investigators of tens of research projects sponsored by national and international founding agencies including China Ministry of Science and Technology, China Natural Science... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
  • Format Forum
  • Level Intermediate
  • Featured Topics ICH
  • Level Intermediate
  • Feature Topics ICH
  • Credit Type ACPE, CME, RN
  • Tags Forum