MEWE40300 Introduction to Regulatory Writing Overview

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.

Applies Towards the Following Certificates

Thank you for your interest in this course. Unfortunately, the course you have selected is currently not open for enrollment. Please complete a Course Inquiry so that we may promptly notify you when enrollment opens.
Required fields are indicated by .