Office of Regulatory Affairs and Quality - Investigational New Drug Workshop

Jun 13

Tuesday, June 13, 2017

1:00 pm - 4:00 pm
Trent Semans Center for Health Education - Great Hall


Kristen Foss, PhD, RAC and Stephanie Pierce, PhD

*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

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