AGENDA

8:00 AMRegistration, Continental Breakfast
9:00 AMIntroductions
 MORNING SESSION: The Basics
9:15 AMEarly Stage Regulatory Drug Pathway Basics: Pre-Clinical Testing, IND and Phase 2 Planning
9:45 AMRegulatory Device and IVD Pathway Basics: Product Classification, 510(k) and PMA
10:15 AMRegulatory Pathways for Other Products
10:45 AMThe Changing Regulatory Landscape: What’s New at the FDA?
12:00 PMLunch Break
12:45 PMKEYNOTE: Product Claims – What Am I?
 AFTERNOON SESSION: Emerging Technologies
1:15 PMBreakthrough Device Designations
1:45 PMSoftware as a Medical Device
2:15 PMRegulation of Biologics through CBER
2:45 PMOUS Regulatory Pathways: Global Challenges
3:15 PMDisaster Panel: Stories from the Field
4:30 PMNetworking/Table Showcase
5:00 PMAdjourn

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