Regulatory Affairs Training Program

The Office of Regulatory Affairs and Quality is pleased to offer the Regulatory Affairs Training Program. This program is open to all interested individuals who register. The program is 6 weeks and consists of weekly online lectures combined with independent study.

This program provides an overview of premarket regulatory work related to drugs, biologics, and medical devices, covering the following topics:

  • Drug Development and FDA Meetings
  • Applicability of FDA Drug Regulations to Clinical Studies
  • IND Content, Format, Review and Maintenance
  • Medical Device Development and FDA Meetings
  • Applicability of FDA Device Regulations to Clinical Studies
  • IDE Preparation, Submission, and Maintenance 

Enrollment to the program occurs on a rolling calendar basis and the program is offered remotely via Zoom. After registering for this program, participants will be contacted prior to the start of that program and so we kindly ask that you limit inquiries regarding session availability.
 

Interested in participating?

If you are interested in participating in the Spring 2024 Regulatory Affairs Training Program which will be held on Fridays from 12 pm – 1 pm EST April 12 – May 17, 2024, please complete the ORAQ Regulatory Affairs Training Program Registration Form  Once you’ve registered for the program, you will receive a welcome email with further details regarding the program one week before the program begins.  If you register for the program the week it begins then you will receive a welcome email the day before the program starts.  No pre-work is required before the program starts.

The welcome email will be sent via a mailing list server.  Please register with an email address that can receive emails from a mailing list server and carefully enter your email address.

Please note that due to limitations of Zoom Webinar, there may be limits to the number of individuals that can attend the sessions live.  All sessions are recorded and available to those who register for the program. 

Questions about the program? 

Please read our FAQs about the program below. If you have a question that is not addressed, please email ORAQ-TrainingProgram@duke.edu.

FAQs