Event Details
Event Title UNC NRP January 2021 Session: Understanding when assays become investigational devices.
Location Online Only
Sponsor UNC Network for Research Professionals
Date/Time 01/21/2021 12:00 PM - 1:00 PM
For more information, contact the event administrator: Sandy Barnhart sandy_barnhart@med.unc.edu
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Presentation Objectives:

Cassie Myers and Mike Matamoros from the UNC OHRE will help us to get a better understanding of the relationship between assays and investigational devices.
 

 

Objectives:

Understand the different stages of assay development and apply the applicable regulatory framework, specifically investigational devices regulations.

Accurately complete the IRBIS application, Assay tables, and consent forms to facilitate IRB review processes

Evaluate when a modification occurs how this will impact the regulatory framework and IRB requirements.

 

 

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Meeting ID: 919 6761 8056

Passcode: 629048

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