Investigational New Drug (IND) Workshop

This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA.

  • Investigational New Drug (IND) Workshop
  • 2015-11-04T12:00:00-05:00
  • 2015-11-04T15:00:00-05:00
  • This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA.
When Nov 04, 2015 from 12:00 PM to 03:00 PM (EST / UTC-500)
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone 919.843.9636
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These course are designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates

IND Workshop

This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or substances (including botanicals and biologics). It will cover the IND process and the regulatory obligations of the sponsor- investigator once an IND is filed with the FDA. This workshop will address the following information:

  • Do I need an IND for my investigation?
  • What are some examples of trials requiring an IND and examples of studies that are IND exempt?
  • What should I include in my IND submission to the FDA?
  • What happens after I submit my IND application to the FDA?
  • How and when should I report Serious Adverse Events (SAEs) once I have an IND?
  • Is my trial required to be registered on Clinicaltrials.gov?
  • Roundtable discussion about the IND process and general questions from participants

Speakers: Preeti Chugha, PhD RAC (Duke) and Carey Hobbes, PhD RAC (Duke)

Details and registration