The Investigational New Drug (IND) Workshop

Apr 10

Tuesday, April 10, 2018 - 1:00pm to 4:00pm

Trent Semans Center for Health Education - Great Hall

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Daniel Tonkin, PhD, RAC & Stephanie Pierce, PhD, RAC

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


Nagorski, Susan