Best Practices for the Preparation, Submission and Maintenance of Sponsor-Investigator INDs

Join the North Carolina Translational and Clinical Sciences (NC TraCS) Institute for lessons in best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA.

Topics Include:
– Defining an investigational drug, including off-label use of FDA approved drugs
– Guidance on determining when the IND regulations apply to research studies
– The preparation and submission of IND applications to FDA
– Review of maintenance and safety reporting requirements
– Participant discussion of case scenarios

This workshop is a CTSA collaboration by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and the Duke Clinical and Translational Science Institute (Duke CTSI). Additional resources can be found on www.ReGARDD.org, a website developed by regulatory experts at UNC, Duke, RTI, and Wake Forest that provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices.

Register at go.unc.edu/IND