Regulatory Writing

This two-course Regulatory Writing certificate program provides rigorous training across the entire regulatory writing cycle. Students will first be introduced to the processes and tools necessary to identify, edit, and contribute components of a biomedical regulatory packet. This 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. They will learn how to navigate the writing and submission process for the FDA in particular. This includes preparing investigational new drug applications, and creating submissions for different categories of biomedical research, including vaccines, devices, and other categories. Furthermore, students will learn how to look at their submission from the perspective of reviewers and to be able to respond to FDA audits. After completing this program, learners will be able to:

• Edit documents and submissions per regulatory standards,
• Collaborate cross-functionally to contribute to biomedical regulatory packets, including the protocols, investigator brochures, and informed consent forms,
• Identify and write for the expectations of particular audiences for regulatory writing
• Edit and submit documents for the FDA for different categories, including drugs, devices, biologics, and vaccines.

Courses and Order of Completion: Two online courses to be completed sequentially.

• REGW11100 - Introduction to Regulatory Writing
• REGW11200 - Regulatory Intelligence

Learn more about the Regulatory Writing certificate.