REGW11100 - Introduction to Regulatory Writing

Course Description

This course is designed to introduce regulatory writing as both a broad and specific skill set. Students will work to develop the tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. For the purposes of this course, the regulatory packet includes the protocol and its amendments, the Investigator's Brochure, informed consent forms, and other submissions to regulatory and oversight bodies such as the IRB and IBC.

Through the completion of this course, students will learn how to:

1. Navigate and respond to the current regulatory environment of biomedicine from pharma and devices to innovative cellular therapies
2. Identify and edit an array of regulatory documents and submissions
3. Collaborate with a team on the roles of legal justification and rationale
4. Begin to tailor their regulatory writing to meet specific audience requirements

“Online self-paced”: Refers to course start and end dates. “Online fixed date” Refers to synchronous session schedule fully available under “Section Notes”

Course Outline

Week 1

• Class outline and logistics
• Brief review of syllabus, assignments, and expectations for the course
• How to make the most of Special Topics
• Introductions
• Regulatory Intelligence
• Discuss ‘open book’ nature of quiz 1
• Special Topics: Drug Promotion webinar

Week 2

• Engaging with regulatory authorities
• Navigating regulations.gov
• Discuss upcoming Call for Comments assignment
• Thinking ahead for final project
• Special Topics: Misbranding notices

Week 3

• Identify types of regulatory writings, their requirements, and intended audiences
• Audience Identification activity
• Discussion Quiz 3/ Regulatory Documents & Language
• Special Topics: Word Choice

Week 4

• Understand where and how regulatory guidance documents originate
• Develop skills in communicating justifications and rationale
• Negotiation activity, part I
• Special Topics: Remote Consent (COVID special topic)

Week 5

• Develop skills in utilizing templates, offering, and accepting revisions
• Consent forms and other specific documents
• Special Topics: Lean Principles & documents

Week 6

• Document Review
• More on teamwork, rationale, and response
• Template/Component discussion pulling from previous discussion responses
• Negotiation activity, part II

Week 7

• Pulling it all together
• Review of Objectives and Outcomes
• Discussion of any additional questions, questions about the final, and responses from Discussion 6

Instructors

• Leah Carter

Applies Toward the Following Certificates

• Medical Writing and Editing : Electives
• Regulatory Writing : Required Courses RW