The Office of Regulatory Affairs and Quality is pleased to offer the Regulatory Affairs Training Program. This program is open to all interested individuals and consists of six online lectures.
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?
We will no longer be offering the Regulatory Affairs Training Program live. In the future, we plan to update our website with recordings of the live program for on-demand access. We anticipate the recordings will be available on the website by Spring 2025.