Curriculum

Be in Demand, in Just Three Months.

Building on the strengths of our Medical Writing and Editing program, Regulatory Writing certificate courses will provide students with highly technical, high-demand, professionally valuable writing skills. You will learn to:

• Identify, edit, and contribute components of a biomedical regulatory packet.
• Navigate the FDA submission and auditing process.
• Prepare investigational new drug applications.
• Create submissions for different categories of biomedical research including vaccines, devices, and other categories.

• Two required courses.
• Class sizes range from ten to twenty students per course.
• Students can complete the certificate in as little as two quarters.

• The program consists of two core requirements with a flexible sequential course progression.
• Students can complete the certificate in as little as three to thirty-six months.
• Class sizes range from ten to twenty students per course.
• Classes are offered remotely with live, interactive, synchronous sessions conducted through zoom.
• Attendance to synchronous sessions is mandatory.
• After successful completion of core requirements, participants will receive a credential certified by the University of Chicago.