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Bethesda North Marriott Hotel and Conference Center

2018 年 04 月 23 日 1:00 下午 - 2018 年 04 月 25 日 4:15 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

Session 9: ICH Guidances from a Global and Regional Perspective

Session Chair(s)

Aloka  Chakravarty, PhD

Aloka Chakravarty, PhD

Director, Data Analytics

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

William  Wang, PhD

William Wang, PhD

President

Merck & Co, Inc, United States

This session will examine a few ICH regulatory guidances, looking at them both from global and regional perspectives. These guidances may include the recently published ICH E9 R1 step 2b draft, the soon-to-be-published ICH E17, and the upcoming ICH E6/E8 renovation.

In this session, we will prepare a case-study scenario for the panelists, then we will let panelists develop their own estimands in advance, which they have to present briefly and subsequently defend during the panel discussion. We will further introduce additional complexities by different intrinsic/extrinsic factors and critical quality factors across region. This will lead to the discussion of E9 R1, E17, and E6/E8 in an implementation setting.

The panel discussion will be mixed with short presentations on the relevant ICH guidance and its regional implementation.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Achieve a better understanding of the current status of key ICH guidance: E9 R1, E17, E6/E8 renovation
  • Discuss the landscape of regulatory statistics in various regions
  • Use the real case-study to illustrate the estimand concept and its MRCT implications

Speaker(s)

Mouna  Akacha, PhD

Speaker

Mouna Akacha, PhD

Novartis Pharma AG, Switzerland

Group Head of Statistical Methodology

Thomas J. Permutt, PhD

Thomas J. Permutt, PhD

FDA, United States

Associate Director for Statistical Science and Policy, OB, OTS, CDER

Toshimitsu  Hamasaki, PhD, MS

Some Observations on Regulatory Statistics Landscape in Japan

Toshimitsu Hamasaki, PhD, MS

National Cerebral and Cardiovascular Center, Japan

Director of Data Science

Devan V. Mehrotra, PhD

Panelist

Devan V. Mehrotra, PhD

Merck Research Laboratories, United States

Senior Director, Biostatistics Department

Xiang  Guo, PhD

An Overview of Regulatory Statistics in China

Xiang Guo, PhD

BeiGene (Beijing) Co., Ltd., China

Global Head of Statistics and Data Science, Vice President

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