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.

Event details

When

May 23, 2012
from 01:00 PM to 04:00 PM

Where

Brinkhous-Bullitt, Room 219

Contact Name

Lori Smith

Contact Phone

9198432883

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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?
Is my trial required to be registered on Clinicaltrials.gov?

Find out at the IND Workshop!

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