events
The Investigational New Drug (IND) Workshop
contact
event sponsored by
Office of Regulatory Affairs and Quality &
Duke Clinical and Translational Science Institute (CTSI), Pratt School of Engineering, and School of Medicine (SOM)
speaker
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
Categories
United States Focus, Lecture/Talk, Workshop/Short Course, and Research