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Wednesday, June 21 • 10:30am - 11:45am
#327: Multiregional Clinical Trials and the ICH E17

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 We will invite panelists and the audience to discuss key issues in the draft guidance.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 Objectives

Describe the evolving regulatory landscape on global drug development; Discuss the key principles and statistical considerations of designing MRCTs outlined in the ICH E17.

Chair

William Wang, PhD

Speaker

Update From the ICH E17 Chair
Yoshiaki Uyama, PhD

Update From the Society-of-Clinical-Trial Working Group
Bruce Binkowitz, PhD, MSc

Thoughts From the China Perspective
Ling Su, PhD


Moderators
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →

Speakers
avatar for Bruce Binkowitz

Bruce Binkowitz

Vice President, Biometrics, Shionogi, Inc.
Dr. Binkowitz is Vice President of Biometrics at Shionogi, Inc. after spending 32 years at Merck and Co. Dr. Binkowitz has 30 years of drug development experience and is a fellow of the ASA. Bruce is involved in the statistical community including serving on the DIA Stat Community... Read More →
avatar for Ling Su

Ling Su

Professor, Shenyang Pharmaceutical University
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session