Program: Regulatory Affairs, M.S. - San Diego State University

Apr 09, 2025

2019/2020 University Catalog

Specific Requirements

In addition to meeting the requirements for classified graduate standing and the basic requirements for the master’s degree as described in Part Four of this bulletin, the student must complete a graduate program consisting of a minimum of 37 units as follows:

Required Courses

Complete 31 units of required courses.

R A 601 - Pharmaceutical, Biotechnology, and Medical Device Industries Units: 3
R A 602 - Food and Drug Law Units: 3
R A 605 - Medical/Scientific Writing for Life Science Professionals Units: 3
R A 750 - Leadership for Change and Continuous Improvement Units: 3
R A 770 - Current Good Manufacturing Practices - General Concepts Units: 3
R A 773 - Medical Device Regulations Units: 3
or
R A 774 - Investigational and Marketing Applications for Drugs and Biologics Units: 3 But not both.
R A 775 - Clinical Trials: Issues in Design, Conduct, and Evaluation Units: 3
R A 779 - International Regulatory Affairs Units: 3
R A 781 - Ethics for Life Science Professionals Units: 3
R A 783 - Effective Communication for Regulatory Science Units: 4

Electives

Complete six units of electives from the following courses.

R A 696 - Advanced Topics in Regulatory Affairs Units: 1-4
R A 705 - Project Planning for the Biomedical Industries Units: 3
R A 771 - Current Good Manufacturing Practices - Advanced Topics Units: 3
R A 772 - Post-Approval Activities Units: 3
R A 773 - Medical Device Regulations Units: 3
or
R A 774 - Investigational and Marketing Applications for Drugs and Biologics Units: 3 But not both.
R A 776 - Validation Aspects of Drugs, Biologics, and Device Product Development and Manufacturing, Including Computer Related Systems and Software Units: 3
R A 778 - Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices Units: 3
R A 797 - Research Units: 1-3
R A 798 - Special Study Units: 1-3