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Session 2 Track 2: Implications of Regulatory Requirements From the Digital Tool Regulators of Health Authorities
Session Chair(s)
Paul Upham
Head, Smart Devices
Roche / Genentech, United States
As new digital health tools (e.g., digital endpoints / biomarkers, etc.) are being developed and introduced into drug clinical trials and launched commercially, health authority regulators are seeking to ensure their safety and efficacy. While there is a growing consensus amongst regulators about how to classify and assess the risk of these new digital tools, there is significant variation across markets and geographies that is critical for the developers and users of these tools to understand. The compliance requirements differ depending on the market, the types and classes of tools (SaMD, sensors, etc.) and can have a significant impact on their development and the execution of the clinical trials that are using them.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the similarities and differences in digital health tool regulations between key regions
- Describe the different compliance activities required for the development and use of these tools in clinical trialsUnderstand how to optimize your compliance activities when your digital tool is deployed in multiple countries
Speaker(s)
Regulatory Considerations During Digital Clinical Innovation
Michael Benecky, PhD
UCB, United States
Senior Director, Global Regulatory Affairs
Addressing regulators Needs While Conducting Clinical Studies with Digital Health Tools in Europe
Seya Colloud, PharmD
F. Hoffmann-La Roche Ltd, Switzerland
Global Regulatory Director