Event sponsored by:
Office of Regulatory Affairs and Quality
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)
Contact:
Susan NagorskiSpeaker:
Rose Beci and Andrea Burns
-Define an investigational drug, including off-label use of FDA approved drugs.
-Provide guidance on determining when the IND regulations apply to research -studies
-Discuss the preparation and submission of IND applications to FDA
-Review maintenance and safety reporting requirements
-Encourage participant discussion of case scenarios