Regulatory Affairs Training Program
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?
The Spring 2023 Regulatory Affairs Training Program will be held on Fridays from 12 pm – 1 pm EST April 14 – May 19, 2023. Please check back soon for information on program registration.
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.
Hi there.
I recently learned about this program and am very interested. As it happens, I am temporarily unemployed and working to learn regulatory coursework during this time.
Would it be possible to get access to the recorded versions of the lectures that I have missed and join with the rest of the cohort?
I am a fast learner, proactive, and seeking any resources possible to pivot my career into RA. Thank you for your consideration.
All the best,
Marissa Kane
B pharm Graduate seeking regulatory job opportunities