The Investigational New Drug (IND) Workshop

February 10, 2023
12:00 pm to 2:00 pm
Zoom

Event sponsored by:

Office of Regulatory Affairs and Quality
Duke Clinical and Translational Science Institute (CTSI)
Pratt School of Engineering
School of Medicine (SOM)

Contact:

Susan Nagorski

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Speaker:

Rose Beci and Andrea Burns

-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