Duke Office of Regulatory Affairs and Quality Presents Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs
The Duke Office of Regulatory Affairs and Quality presents "Best Practice for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs" on November 19-20 in Hock Auditorium from 9 a.m. to 12 p.m. each day. This workshop will also include an update on new institutional requirements for regulatory submissions at Duke. Light refreshments will be serviced.
Day one speakers include Rachel Johnson, PhD, RAC; and Daniel Tonkin, PhD, RAC; who will present for "The Investigational New Drug (IND) Workshop. This workshop will define an investigational drug, including off-label use jof 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; and encourage participant discussion of case scenarios.
Day two speakers include Kelly Lindblom, PhD, RAC; and David Jensen, PhD, RAC; who will present for "The Investigational Device Exemption (IDE) Workshop. This workshop will discuss FDA's approach to regulation of devices in clinical studies and for marketing; provide guidance on when the IDE regulations apply and discuss possible exemptions; review significant risk and non-significant risk device studies; discuss the preparation, submission, and maintenance of IDE applications; and encourage participant discussion of case scenarios.