
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 |