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Duke Regulatory Affairs Training Program
May 12 @ 12:00 pm - 1:00 pm
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.