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Thursday, June 18 • 5:00pm - 6:00pm
#511 OD: ON DEMAND - Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

Romi Singh, PhD

Speaker

PMDA Update
Yoko Aoi, PharmD

FDA Update
Aloka Chakravarty, PhD

Industry Update
Stuart Green, MD


Speakers
avatar for Aloka Chakravarty

Aloka Chakravarty

Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and... Read More →
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 →
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 Stuart Green

Stuart Green

Vice President, Clinical Development, Merck & Co., Inc.
Stuart Green trained in Internal Medicine, Pulmonary Medicine and Critical Care Medicine at Duke University Medical Center, Durham, NC USA. In addition to clinical work, his major research efforts focused on the structure and function of airway G-protein coupled receptors, primarily... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session