Course Requirements

Prerequisites:

• 410.303 Bioscience for Regulatory Affairs or One semester of Biochemistry and Cell Biology at the undergraduate or graduate level
• An undergraduate degree in the life sciences or engineering from a four-year college with at least a 3.0 on a 4.0 scale in the latter half of undergraduate studies

10-Graduate Course Program:

• 410.673 Biological Processes in Regulatory Affairs
• 410.649 Introduction to Regulatory Affairs (formerly Regulatory Processes for Domestic and Global Biotech Products)
• 410.627 Product Development: Research to Manufacturing
• 410.683 Introduction to cGMP Compliance
• 410.651 Clinical Development of Drugs and Biologics
• 410.676 Food and Drug Law--taken at any point before the Practicum

Practicum (One):

• 410.679 Practicum in Bioscience Regulatory Affairs--taken at the end of the program after all cores have been completed and as the 9th or 10th course.

Electives:

Pick three electives from the MS in Biotechnology Program for which you have met the prerequisites or have received permission from the program committee. See Course Descriptions for a list of courses.

Course Waiver

Applicants and students with extensive experience or relevant coursework may request a waiver for a core required course. If the waiver is granted, students must replace the course with an elective course. Please include the request in your application.

Johns Hopkins University
1717 Massachusetts Ave. NW, Washington DC, 20036
Tel. 800-847-3330
Web: http://advanced.jhu.edu, Email: aapwebmaster@jhu.edu