Curriculum

Be in Demand, in Just Three Months.

Building on the strengths of our Medical Writing and Editing program, Regulatory Writing 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

• Two-course program, each seven weeks in length
• All remote courses start on a Monday with a full week of self-study activities in Canvas, our learning management system
• Weekly, self-paced learning and materials are time-sensitive and must be completed within required timeframes
• Weekly, self-paced learning in Canvas leads to one synchronous session per week
• When registering for a course, "Online self-paced" refers to the course's beginning and end dates, "Online fixed dates" refer to synchronous sessions.
• Synchronous sessions are conducted through Zoom
• Attendance to synchronous sessions is mandatory