Tuesday, October 12, 2021
Welcome Remarks10:00 AM
Keynote10:10 AM
Impact of the EU-MDR on Digital Health Companies10:40 AM
Regulating Digital Health Apps: An International Overview and Country Case Studies11:00 AM
Break11:50 AM
SESSION 1 Q&A12:10 PM
Evaluating Risk and Benefit in the Digital Mental Health Space: Practical and Regulatory Approaches12:40 PM
The Role of Registry Networks in Supporting a National System for Device Surveillance1:00 PM
Working Group Activities1:20 PM
Break1:40 PM
Considerations for Implementing Decentralized or Flexible Clinical Trials1:55 PM
Advances in Decentralized Trials and Regulatory Considerations2:15 PM
Break3:05 PM
SESSION 2 Q&A3:20 PM
Recap & Closing Remarks3:50 PM
End of Day 1 & Posters Q&A Sessions4:00 PM

Working Groups

Wednesday, October 13, 2021
Developments in Digital Pathology, Tissue Imaging, and Artificial Intelligence 
Real-world Evidence for Digital Health Applications 
Challenges and Opportunities in Pediatric Device Development 9:00 AM - 12:00 PM
Education in Regulatory Science10:00 AM - 12:00 PM