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

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 IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.

Topics Include:

– The FDA’s approach to regulation of devices in clinical studies and for marketing
– Guidance on determining when the IND regulations apply to research studies
– Significant risk and non-significant risk device studie
– Preparation, submission, and maintenance of IDE applications
– 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