Event sponsored by:
Office of Regulatory Affairs and Quality
Biomedical Engineering (BME)
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)
School of Nursing (SON)
Contact:
Susan NagorskiSpeaker:
Rachel Johnson, PhD, RAC 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