Interactive Breakout Session: Considerations for Regulatory Acceptance of DHT-Derived Endpoints
Time: 3:00 pm
day: Day One
Details:
Splitting into breakout groups to solve scenario-based challenges, leveraging diverse cross-functional expertise of stakeholders in the room, presenting back and learning from the experience and approach of each working group.
Discussion Questions include:
- What is the advantage of qualifying vs validating digital endpoint measures for individual drug development programs?
- What would be the best strategy for Health Authority consultations, including timing of Health Authority interactions, what information to discuss and how to prepare briefing package?
- How to define whether Digital Health Technology is fit-for-purpose?
- How can we extend consortium learnings to particular context of use?
