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Tuesday, June 29 • 10:00am - 11:00am
#221 SL: Global Harmonization of Complex and Innovative Trial Designs

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-596-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Andrew Thomson, PhD, MA, MS


FDA Update
James Travis, PhD

Industry Update
Heinz Schmidli, PhD, MSc

Industry Update
Scott M Berry, PhD

avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
avatar for Heinz Schmidli

Heinz Schmidli

Executive Director, Statistical Methodology, Novartis Pharma AG, Switzerland
Heinz Schmidli works as an Executive Director in the Statistical Methodology group at Novartis, Basel, Switzerland. Since he joined the group in 2007, he contributes to the development of innovative approaches for the design and analysis of clinical trials, with a focus on Bayesian... Read More →
avatar for James Travis

James Travis

Senior Staff Fellow, OB, OTS, CDER, FDA, United States
James Travis is a statistical reviewer in the Division of Biometrics II in the Office of Biostatistics in CDER. James joined the Agency in 2014 following completion of his PhD at the University of Maryland, Baltimore County. He is a member of the pediatric and maternal health statistical... Read More →

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming COVID-19 - Pandemic,Regulator Thinking,Innovative Trial Design,Collaboration
  • Featured Topics COVID-19 - Pandemic,Regulator Thinking,Innovative Trial Design,Collaboration
  • Tags Session