The Regulatory Affairs Training Program is 6 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.
Enrollment to the program occurs on a rolling calendar basis and the program is offered remotely via Webex.
The program is open to all interested individuals and is free of charge. There is no formal application process and no stipend is available.
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.