AGENDA

image
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

 

< BACK TO PROGRAMS PAGE