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ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines
Session Chair(s)
Romi Singh, PhD
Head, Regional Regulatory Sciences, Asia
Pfizer Inc, United States
The session presenters are experts from the industry and regulatory agencies who were involved in drafting the ICH E17 guidelines. This session will provide detailed overview of how to interpret, apply and implement the ICH E17 guidelines.
Learning Objective : Interpret the principles of E17 guidelines to allow for simultaneous drug development and drug registration; Design and implement the results of multiregional clinical trials using the E17 guidelines; Discuss new concepts such as new definition of a region, e.g., pooled region, regulatory region or a geographic region and examine the consistency of treatment effect as well as for pooled sub-populations.
Speaker(s)
PMDA Update
Yoko Aoi, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug V
FDA Update
Aloka Chakravarty, PhD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics
Industry Update
Stuart Green, MD
Merck & Co., Inc., United States
Vice President, Clinical Development
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