Event Details
Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs Return to listing

  Description
Best Practices for the Preparation, Submission, and Maintenance
of Sponsor-Investigator INDs and IDEs
 
November 6 and 8, 2018
in Brinkhous-Bullitt Room 219
9:00am to 12:00pm
 
 
The IND workshop on November 20, 2018 (rescheduled from November 6) 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. 
 
Speakers:
Daniel Tonkin, PhD, RAC
Kristen Foss, PhD, RAC

 

Topics Include:
Define an investigational drug, including off-label use of FDA approved drugs
Provide guidance on determining when the IND regulations apply to research studies
Discuss the preparation and submission of IND applications to FDA
Review maintenance and safety reporting requirements
Encourage participant discussion of case scenarios 
 
 
The IDE workshop on November 8, 2018 will offer best practices when conducting trials using FDA approved and non-approved devices.   It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA.
 
Speakers:
Kelly Lindblom, PhD, RAC
Stephanie Pierce, PhD, RAC
 
Topics Include:
Discuss FDA's approach to regulation of devices in clinical studies and for marketing
Provide guidance on when the IDE regulations apply and discuss possible exemptions
Review significant risk and non-significant risk device studies
Discuss the preparation, submission, and maintenance of IDE applications
Encourage participant discussion of case scenarios 
 
 

This workshop is a CTSA collaboration by the North Carolina Translational and Clinical Sciences (NC TraCS) Institute and the Duke Clinical and Translational Science Institute (Duke CTSI). Additional resources can be found on www.ReGARDD.org, a website developed by regulatory experts at UNC, Duke, RTI, and Wake Forest that provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices. 

  Location: Brinkhous-Bullitt Room 219
  Date: 11/08/18 - 11/20/18
  Time: (See session details)
  Sponsor: NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
  Price: Free
     
  For more information, contact the event administrator: Amanda Wood amanda_wood@med.unc.edu

Session Date Time Additional Fees
Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator IDEs 11/08/2018 9:00 AM - 12:00 PM $ 0.00
Best Practices for the Preparation, Submission and Maintenance of Sponsor-Investigator INDs 11/20/2018 9:00 AM - 12:00 PM $ 0.00

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