Executive Workshop: A Global Perspective on the Interface Between Drug & Device Regulation in Clinical Studies
Time: 9:00 am
day: day 2
Details:
- Significance of global clinical design in device regulatory affairs
- Discussing strategies for incorporating digital technologies into clinical studies and patient care
- Addressing challenges in patient selection, monitoring, and data collection when integrating devices into clinical trials
- Exploring strategies for addressing unmet patient needs through innovative drug-device combinations
- Expectations from CDx partnerships, with respect to diagnostic testing, to maintain good practice
- An exploration of the LDT Final Rule
