Menu Back toGlobal Harmonization of Complex and Innovative Trial Designs
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
DIA 2021 Global Annual Meeting
Global Harmonization of Complex and Innovative Trial Designs
Andrew Thomson, PhD, MA, MS
- Statistician, Methodology Taskforce
- European Medicines Agency, Netherlands
This session will include details in which complex and innovative designs are available to use to answer which questions, the global regulatory acceptability of such designs, and how it may be possible to conduct a single global development even if regional differences exist.
Learning Objective : Distinguish and describe complex innovative designs that are increasingly common in drug development; Discuss different regional views on the evaluation of such designs; Appraise and choose between different designs that answer complex questions.
James Travis, PhD
- Senior Staff Fellow, OB, OTS, CDER
- FDA, United States
Heinz Schmidli, PhD, MSc
- Executive Director, Statistical Methodology
- Novartis Pharma AG, Switzerland
Scott M Berry, PhD
- President and Senior Statistical Scientist
- Berry Consultants LLC, United States