Menu
Home
Agenda
About the Center
Register
Tuesday, October 12, 2021
Welcome Remarks
10:00 AM
Keynote
10:10 AM
Impact of the EU-MDR on Digital Health Companies
10:40 AM
Regulating Digital Health Apps: An International Overview and Country Case Studies
11:00 AM
Break
11:50 AM
SESSION 1 Q&A
12:10 PM
Evaluating Risk and Benefit in the Digital Mental Health Space: Practical and Regulatory Approaches
12:40 PM
The Role of Registry Networks in Supporting a National System for Device Surveillance
1:00 PM
Working Group Activities
1:20 PM
Break
1:40 PM
Considerations for Implementing Decentralized or Flexible Clinical Trials
1:55 PM
Advances in Decentralized Trials and Regulatory Considerations
2:15 PM
Break
3:05 PM
SESSION 2 Q&A
3:20 PM
Recap & Closing Remarks
3:50 PM
End of Day 1 & Posters Q&A Sessions
4:00 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 Science
10:00 AM - 12:00 PM