Complex Innovative Design - What’s in a Name? A Global Perspective on the Changing Design Landscape for Clinical Trials and What That Means for Developers

1:45 PM - 2:45 PM (PDT), Tuesday, June 14, 2022

Complex Innovative Design – what’s in a name? A global perspective on the changing design landscape for clinical trials and what that means for developers in the EU but might be less well known by developers. The purpose of this session is to thus introduce the FDA’s CID program and the recent success from it. A case study from one of the companies involved will be presented. This will be contrasted with a summary of the options for advice in the EU and the types of questions posed so far


 


 

Moderator
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Executive Director, US Lead, Global Regulatory Policy
Merck
Speakers
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Executive Director of Biostatistics, Head of Design & Innovation
Amgen
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Deputy Director, Office of Biostatistics
FDA
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Statistician
European Medicines Agency (EMA)
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Senior Advisor
Eli Lilly and Company