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
Interested in participating?
The Fall 2024 session has started and will be the last live session of the program. We are not able to accommodate late registration.
We anticipate recordings from the live program will be available on our website for on-demand access in Spring of 2025.
Please read our FAQs about the program below. If you have a question that is not addressed, please email ORAQ-TrainingProgram@duke.edu.