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Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability
Session Chair(s)
Lina AlJuburi, PharmD, MSc
Head, Global 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
Max Wegner, PharmD, RPh
Bayer AG, Germany
Head Regulatory Affairs
Industry Perspective
Steve Berman, MPH
BIO, United States
Deputy Vice President, Science and Regulatory Affairs
Panelist
Anindita Saha
FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of Excellence
Industry Update
Gul Erdemli, MD, PhD
Novartis Pharmaceuticals Corporation, United States
Global Program Regulatory Director
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