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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)
FDA Update
James Travis, PHD
FDA, United States
Lead Mathematical Statistician, OB, OTS, CDER
Industry Update
Heinz Schmidli, PHD, MSC
Novartis Pharma AG, Switzerland
Executive Director, Statistical Methodology
Industry Update
Scott Berry, PHD
Berry Consultants LLC, United States
President and Senior Statistical Scientist