Event Details
Event Title Investigational Device Exemption (IDE) Workshop
Location Brinkhous-Bullitt Building, Room 219, UNC-CH Campus
Sponsor NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
Date/Time 05/30/2014 1:00 PM - 4:00 PM
For more information, contact the event administrator: Marie Rape mzeldin@med.unc.edu
Sorry, This event has expired
 

This course will offer best practices when conducting trials using FDA approved and non-approved devices.   It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.  This workshop will address the following information:

This course is designed for anyone directly involved in conducting investigator-initiated trials:

This workshop is a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).

The IND and IDE Workshops have each been pre-approved for 3 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training. 

UNC - Chapel Hill