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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines

Session Chair(s)

Romi  Singh, PhD

Romi Singh, PhD

Professor of Practice, Regulatory Sciences

Northeastern University, 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)

Yoko  Aoi, PhD

PMDA Update

Yoko Aoi, PhD

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Deputy Review Director, Office of New Drug V

Aloka  Chakravarty, PhD

FDA Update

Aloka Chakravarty, PhD

Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

Director, Data Analytics

Stuart  Green, MD

Industry Update

Stuart Green, MD

Merck & Co., Inc., United States

Vice President, Clinical Development

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