The Office of Regulatory Affairs and Quality is pleased to offer the Regulatory Affairs Training Program. This program provides an overview of the regulatory affairs profession and offers an in-depth look at premarket regulatory work related to drugs, biologics, and medical devices. The program is open to all interested individuals and is free of charge. There is no formal application process and no stipend is available.
The Regulatory Affairs Training Program is 6-7 weeks and consists of weekly discussions and lectures combined with independent study. There will be opportunities to review and discuss different types of regulatory submissions, including Investigational New Drug applications (INDs) and Investigational Device Exemptions (IDEs). Participants will also have the opportunity to attend an IRB meeting on-site. Training Program alumni will be invited back for an annual networking reunion.
Enrollment to the program occurs on a rolling calendar basis and we offer both on-site and remote programs periodically throughout the year. You will be contacted prior to the start of the next available program and so we kindly ask that you limit inquiries regarding session availability.
Interested in participating?
To inquire about the program, please email ORAQ-TrainingProgram@duke.edu.
To register for the program, please click the button below.