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 21, 2013
from 01:00 PM to 04:00 PM
Where Brinkhous-Bullitt, Room 219
Contact Name
Contact Phone (919) 843-9514
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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
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    This course is designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates
  • To register, please visit http://tinyurl.com/bmstwp4

     

    Investigational New Drug (IND) and Investigational Device Exemption (IDE) Workshops
    These workshops are a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).

    The IND and IDE Workshops have each been pre-approved for 3 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training. For nurses or others in need of Continuing Education Units, 3 CEUs are available at a cost of $6 per day (please provide payment in the form of a check and your PID number on the day of training).

    More information about this event…