Regulatory Considerations for the Use of Healthcare Technologies for Patient Selection, Monitoring & Endpoint Analysis in Medicinal Product Clinical Trials
Time: 11:35 am
day: Day Two Track B
Details:
- Use of a healthcare technology in a clinical trial (similarities and differences between IVDs and digital technologies)
- Distinction in regulatory pathways between enrollment/ selection methods and endpoint validation
- Considerations for pharma companies in assessing regulatory capabilities of partners with innovative digital technologies
