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Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability
Session Chair(s)
Lina AlJuburi, PHARMD, MSC
Head, Regulatory Science and Policy, North America, Sanofi, United States
This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.
Learning Objective : Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.
Speaker(s)
Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
Senior Vice President,Head Regulatory Affairs, Bayer, Germany
Industry Perspective
Deputy Vice President, Science and Regulatory Affairs, BIO, United States
Panelist
Associate Director Strategic Initiatives, Digital Health Center of Excellence, C, FDA, United States
Industry Update
Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States
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