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DIA 2021 Global Annual Meeting

Global Harmonization of Complex and Innovative Trial Designs

Session Chair(s)

Andrew Thomson, PhD, MA, MS

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

FDA Update

James Travis, PhD

  • Senior Staff Fellow, OB, OTS, CDER
  • FDA, United States
Heinz Schmidli, PhD, MSc

Industry Update

Heinz Schmidli, PhD, MSc

  • Executive Director, Statistical Methodology
  • Novartis Pharma AG, Switzerland
Scott M Berry, PhD

Industry Update

Scott M Berry, PhD

  • President and Senior Statistical Scientist
  • Berry Consultants LLC, United States