Event sponsored by:
Office of Regulatory Affairs and Quality
Pratt School of Engineering
School of Medicine (SOM)
Contact:
Susan NagorskiSpeaker:
Rachel Johnson, PhD, RAC and Katherine Deland, PhD
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
Review case scenarios