Regulatory Intelligence
- Course Code:
- REGW11200
- Duration:
- 7 weeks
- Investment:
- $1,640.00
This advanced course will cover FDA submissions as well as regulatory writing and documents associated with the major clinical trial milestones, responding to regulatory review, and writing about regulations. Students will learn the intricacies of FDA device, drug, and biologic submissions; gain knowledge and familiarity with the preparation and submission of specific FDA documents and correspondence in accordance with requirements and best practices; further understand the regulatory writing components of clinical trials from start up to close out; and begin to think about regulatory documents from a reviewer’s perspective and practice drafting responses.
Course Outline
- Brief review of syllabus, assignments, and expectations for the course, and how to make the most of Special Topics
- Introductions
- Regulatory Writing vs Medical Writing
- Discuss Quiz 1 (research agility) in the context of upcoming coursework
- Thinking ahead for final project
- FDA submissions for Drugs Special Topics: Single Patient INDs
- FDA submissions for Devices
- Special Topics: Real World Data Special Topics: Intended Use
- FDA submissions for Biologics and Vaccines
- Combination Products Special Topics: Biologics vs Drug
- Regulatory Writing Through Clinical Trial Milestones
- Combination products and merging knowledge
- Responding to Regulatory Review
- Special Topics: Writing SOPs and Policies
- Writing About Regulations
- Regulatory Intelligence, part II
- Special Topics: Do off-label restrictions limit free speech?
- Collaboration at different phases
- Any outstanding question or concerns
Final is due.
Upcoming Sections
| Section | Location | Dates | Instructor | Meetings | Register |
|---|---|---|---|---|---|
| 10/26/2026 - REGW11200 Autumn - Online | Online | Oct 26, 2026 – Dec 12, 2026 | Leah Carter, Pamela Gonzalez | Every Saturday from 10:00am to 11:00am CT | Register Now (opens in new tab) |