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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 We will invite panelists and the audience to discuss key issues in the draft guidance.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
Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... 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 Communit... Read More →
avatar for Ling Su

Ling Su

Venture Partner, Lilly Asia Ventures
Dr. Ling Su is Professor in Shenyang Pharmaceutical University and Director of the newly established Institute of Drug Regulatory Science, the first of its kind in China. He is also a Venture Partner with Lilly Asia Ventures. He has more than 25 years of industry and government e... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety m... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Bill has over 23 years of experience in the pharmaceutical industry. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). He was a recipient of the DIA... Read More →

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