Duke SOM: Investigational New Drug Workshop

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational New Drugs (INDs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IND Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

This workshop will:

• 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

Presenters

Rachel Johnson, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine
Katherine Deland, PhD, Regulatory Affairs Scientist, Duke University School of Medicine

Register

NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IDE workshop Mar 12