The Investigational New Drug (IND) Workshop
Tuesday, April 10, 2018 - 1:00pm to 4:00pm
Tuesday, April 10, 2018 - 1:00pm to 4:00pm
Trent Semans Center for Health Education - Great Hall
Presenter
Daniel Tonkin, PhD, RAC & Stephanie Pierce, PhD, RAC
Details
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
Contact
Nagorski, Susan
919-668-0502
susan.nagorski@dm.duke.edu