| 8:00 AM |
Registration, Continental Breakfast |
| 9:00 AM |
Introductions |
| |
MORNING SESSION: The Basics |
| 9:15 AM |
Early Stage Regulatory Drug Pathway Basics: Pre-Clinical Testing, IND and Phase 2 Planning |
| 9:45 AM |
Regulatory Device and IVD Pathway Basics: Product Classification, 510(k) and PMA |
| 10:15 AM |
Regulatory Pathways for Other Products |
| 10:45 AM |
The Changing Regulatory Landscape: What’s New at the FDA? |
| 12:00 PM |
Lunch Break |
| 12:45 PM |
KEYNOTE: Product Claims – What Am I? |
| |
AFTERNOON SESSION: Emerging Technologies |
| 1:15 PM |
Breakthrough Device Designations |
| 1:45 PM |
Software as a Medical Device |
| 2:15 PM |
Regulation of Biologics through CBER
|
| 2:45 PM |
OUS Regulatory Pathways: Global Challenges |
| 3:15 PM |
Disaster Panel: Stories from the Field |
| 4:30 PM |
Networking/Table Showcase |
| 5:00 PM |
Adjourn |
