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Multiregional Clinical Trials and the ICH E17
Session Chair(s)
William Wang, PHD
Executive Director
Merck & Co, Inc, United States
This session will start with brief presentations by the ICH E17 working group members on the background, objective, and scope of the E17 guidance, the basic principles and key statistical considerations and public comments and preliminary responses. We will invite panelists and the audience to discuss key issues in the draft guidance.
Learning Objective : Describe the evolving regulatory landscape on global drug development; Discuss the key principles and statistical considerations of designing MRCTs outlined in the ICH E17.
Speaker(s)
Update From the ICH E17 Chair
Yoshiaki Uyama, PHD, MS, RPH
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Update From the Society-of-Clinical-Trial Working Group
Bruce Binkowitz, PHD, MSC
Arcutis Biotherapeutics, Inc., United States
Vice President, Biometrics
Thoughts From the China Perspective
Ling Su, PHD
Yeehong Business School, China
Research Fellow