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.

When May 23, 2012
from 01:00 PM to 04:00 PM
Where Brinkhous-Bullitt Building, Room 219
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This workshop will address the following information:

  • Do I even 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?
  • Roundtable discussion about the IND process and general questions from participants

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