The Investigational New Drug (IND) Workshop
Tuesday, June 13, 2017 - 1:00pm to 4:00pm
Tuesday, June 13, 2017 - 1:00pm to 4:00pm
Trent Semans Center for Health Education - Great Hall
Presenter
Kristen Foss, PhD, RAC and Stephanie Pierce, PhD
Details
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