Regulatory Affairs Training Program by Duke University School of Medicine

The Spring 2024 Regulatory Affairs Training Program will be held on Fridays from 12 pm – 1 pm EST April 12th – May 17th, 2024.

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

https://medschool.duke.edu/research/research-support/research-support-offices/office-regulatory-affairs-and-quality-1