What You Should Know When Conducting Trials with Drugs or Devices- An Opportunity for Regulatory Guidance and Discussion

Investigational Device Exemption Workshop

When May 19, 2011
from 01:00 PM to 04:00 PM
Where Brinkhous-Bullitt Building, Room 219
Contact Name
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Calling all Investigators, Regulatory Personnel, Clinical Research Nurses and Clinical Research Associates (CRAs)!

This course will offer best practices when conducting clinical trials using FDA approved and non-approved drugs or devices.  It will cover the IND/IDE process and the regulatory obligations of the sponsor- investigator once an IND/IDE is filed with the FDA. 

Some of the topics for discussion will be:

  • Do I even need an IND or IDE to conduct my research?
  • Examples of when an IND or IDE may be required
  • What should be included in my IND or IDE application?
  • How do I report a serious adverse event (SAE) when I have an IND or IDE?
  • Is my trial required to be registered on Clinicaltrials.gov?

We have divided this workshop into 2 days.  You may sign up for either the IND, IDE or both workshops, depending on your specific interests and investigational needs.

  • May 18th, 1-4 PM: Investigational New Drug Workshop
  • May 19th, 1-4 PM: Investigational Device Exemption Workshop

CEUs are available. Details will be provided at each workshop.

For general questions that you would like to address at the workshop, please email Amy Franklin (amy_franklin@med.unc.edu).  We will try to address your question if time permits.

Location: Brinkhous-Bullitt Building, Room 219
Start Date: Wednesday, May 18, 2011
End Date:  Thursday, May 19, 2011
Link to register:  http://tracs.unc.edu/IND_IDE_Workshops2011

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