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Session 9: ICH Guidances from a Global and Regional Perspective
Session Chair(s)
Aloka Chakravarty, PhD
Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
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)
Speaker
Mouna Akacha, PhD
Novartis Pharma AG, Switzerland
Group Head of Statistical Methodology
Thomas J. Permutt, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Some Observations on Regulatory Statistics Landscape in Japan
Toshimitsu Hamasaki, PhD, MS
National Cerebral and Cardiovascular Center, Japan
Director of Data Science
Panelist
Devan V. Mehrotra, PhD
Merck Research Laboratories, United States
Senior Director, Biostatistics Department
An Overview of Regulatory Statistics in China
Xiang Guo, PhD
BeiGene (Beijing) Co., Ltd., China
Global Head of Statistics and Data Science, Vice President