Biostatistics Industry and Regulator Forum
Session 9: ICH Guidances from a Global and Regional Perspective
- Acting Deputy Director, Office of Biostatistics, OTS, CDER
- FDA, United States
- Executive Director, Clinical Safety Statistics, BARDS
- Merck Research Laboratories, United States
Aloka Chakravarty, PhD
William Wang, PhD
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.