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Session 4: Regulatory Approaches to Use of Digital Tools: Where are we now and where do we need to go?
Session Chair(s)
Megan Doyle, JD, MPH
Global Policy Lead, Digital Health, Diagnostics, Oncology
Amgen, United States
Anindita Saha
Associate Director Strategic Initiatives, Digital Health Center of Excellence
FDA, United States
This session will provide an overview of open regulatory questions related to use of digital tools in clinical trials. The session will ground participants in the current regulatory issues in this space, to set a baseline for the rest of the meeting. Panelists will discuss where we are now, where we are going, and what questions need to be answered to get us there.
Learning Objective : At the conclusion of this session, participants should be able to:
- Educate meeting participants in the regulatory issues pertaining to use of digital tools in clinical trials
- Discuss important regulatory questions related to the use of these tools in clinical trials
- Identify where sponsors are going in the future and what regulatory questions need to be answered to advance the field
Speaker(s)
Existing Frameworks for Use of Digital Tools in Clinical Studies of Medicinal Products
Elizabeth Kunkoski, MS
FDA, United States
Health Science Policy Analyst, OMP, CDER
Device Regulations and Digital Tools in Clinical Trials
Matthew Diamond, MD, PhD
FDA, United States
Chief Medical Officer, Digital Health Center of Excellence, CDRH
Implications of the Regulatory Status of Different Tools
Samantha Roberts, PhD
Genentech, A Member of the Roche Group, United States
Group Director, US Regulatory Science