Carolyn Mahler
This course introduces 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.
Skills / Knowledge
- Understand the current regulatory landscape and navigate related resources.
- Identify types of regulatory writing and their intended audiences.
- Edit audience-specific documents and submissions following specified requirements.
- Contribute to a team with the ability to revise and offer rationale for a variety of regulatory documents and submissions.
Issued on
July 19, 2024
Expires on
Does not expire