MEWE40300 - 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, and 4) begin to tailor their regulatory writing to meet specific audience requirements.