The Investigational New Drug (IND) Workshop
Tuesday, June 13, 2017
1:00 pm - 4:00 pm
Kristen Foss, PhD, RAC and Stephanie Pierce, PhD
Sponsor(s): School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical and Translational Science Institute (CTSI), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Cost: Free but REGISTRATION REQUIRED
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
- Encourage participant discussion of case scenarios
Type: WORKSHOP/SHORT COURSE
