Learning from the Past & Constructing Frameworks to Breakdown the Requirements for Regulatory Acceptance of Digital Measures

Time: 9:00 am
day: Workshop Day- Track B


With only one digital biomarker approved by regulatory bodies, there is still ambiguity regarding the requirements and pathway needed for a digital biomarker to receive regulatory acceptance. Join this workshop to discuss the current requirements needed for digital biomarker approval, as well as the steps that can be taken by industry developers to best instil confidence from regulatory bodies.

Workshop highlights include:

  • Understanding the journey of a digital measure to gain regulatory approval
  • Lessons learned from previous interactions with regulatory bodies: what has worked best historically?
  • Generating frameworks of evidence generation and validation to demonstrate the feasibility to regulatory bodies