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?
Registration for the Fall 2023 Regulatory Affairs Training Program is now closed to enrollment. We are unable to accept any late enrollments.
If you are interested in participating in the next program and would like to be notified when the registration form is available, please complete the ORAQ Regulatory Affairs Training Program Interest Form.
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.