REGW11200 - Regulatory Intelligence
Course Description
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
Class outline and logistics
Week 1
- 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 course work
- Thinking ahead for final project
- FDA submissions for Drugs Special Topics: Single Patient INDs
Week 2
- FDA submissions for Devices
- Special Topics: Real World Data Special Topics: Intended Use
Week 3
- FDA submissions for Biologics and Vaccines
- Combination Products Special Topics: Biologics vs Drug
Week 4
- Regulatory Writing Through Clinical Trial Milestones
- Combination products and merging knowledge
Week 5
- Responding to Regulatory Review
- Special Topics: Writing SOPs and Policies
Week 6
- Writing About Regulations
- Regulatory Intelligence, part II
- Special Topics: Do off label restrictions limit free speech?
Week 7
- Writing About Regulations
- Regulatory Intelligence, part II
- Special Topics: Do off label restrictions limit free speech?
FINAL is due in week 8
Applies Toward the Following Certificates
- Regulatory Writing : Required Courses RW