返回 Agenda
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
Executive Director, 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
Group Head of Statistical Methodology, Novartis Pharma AG, Switzerland
Speaker
Thomas J. Permutt, PHD
Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA, United States
Toshimitsu Hamasaki, PHD, MS
Director of Data Science, National Cerebral and Cardiovascular Center, Japan
Some Observations on Regulatory Statistics Landscape in Japan
Devan V. Mehrotra, PHD
Senior Director, Biostatistics Department, Merck Research Laboratories, United States
Panelist
Xiang Guo, PHD
Global Head of Statistics and Data Science, Vice President, BeiGene (Beijing) Co., Ltd., China
An Overview of Regulatory Statistics in China