The Investigational New Drug (IND) Workshop

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