Event Title | Investigational New Drug (IND) 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 | 05/29/2014 1:00 PM - 4:00 PM |
This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA. This workshop will address the following information:
This course 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.