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Digital Technology in Clinical Trials

This event is now offered in a new entirely virtual format.

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

Megan Doyle, JD, MPH

  • Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
  • Amgen, United States
Anindita Saha

Anindita Saha

  • Assistant Director, Digital Health Center of Excellence, CDRH
  • 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)

Elizabeth Kunkoski, MS

Existing Frameworks for Use of Digital Tools in Clinical Studies of Medicinal Products

Elizabeth Kunkoski, MS

  • Health Science Policy Analyst, OMP, CDER
  • FDA, United States
Matthew Diamond, MD, PhD

Device Regulations and Digital Tools in Clinical Trials

Matthew Diamond, MD, PhD

  • Chief Medical Officer, Digital Health Center of Excellence, CDRH
  • FDA, United States
Samantha Roberts, PhD

Implications of the Regulatory Status of Different Tools

Samantha Roberts, PhD

  • Group Director, US Regulatory Policy
  • Genentech, A Member of the Roche Group, United States

Contact us

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Preconference Short Courses

Short Course 1: Approaches for Developing Novel Digital Endpoints for Medical Product Development

Additional Information

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Digital Technology in Clinical Trials Resource Kit