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 Webex. 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?
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.