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Global Harmonization of Complex and Innovative Trial Designs
Session Chair(s)
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.
Speaker(s)
James Travis, PHD
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
FDA Update
Heinz Schmidli, PHD, MSC
Executive Director, Statistical Methodology, Novartis Pharma AG, Switzerland
Industry Update
Scott Berry, PHD
President and Senior Statistical Scientist, Berry Consultants LLC, United States
Industry Update
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