In addition to meeting the requirements for classified graduate standing and the basic requirements for the master’s degree as described in the Graduate Bulletin under “Courses and Curricula”, students must complete a graduate program consisting of a minimum of 37 units as follows.
All degree requirements must be completed within seven (7) years of starting your coursework.
Complete 31 units of required courses:
RA 601: Pharmaceutical, Biotechnology and Medical Device Industries (3)
RA 602: Food and Drug Law (3)
RA 605: Medical & Scientific Writing for Life Science Professionals (3)
RA 750: Leadership for Change and Continuous Improvement (3)
RA 770: Current Good Manufacturing Practices – General Concepts (3)
RA 773: Medical Device Regulations (3)
OR
RA 774: Investigational and Marketing Applications for Drugs and Biologics (3)
RA 775: Clinical Trials: Issues in Design, Conduct and Evaluation (3)
RA 779: International Regulatory Affairs (3)
RA 781: Ethics for Life Science Professionals (3)
RA 783: Effective Communication for Regulatory Science (3)
RA798: Special Study (1)
Complete 6 units of electives from the following courses:
RA 696: Advanced Topic in Regulatory Affairs (1-4)
Various “hot topic” courses in Regulatory Affairs.
RA 696-A: eSTAR Submissions (1)
RA 696-B: In Vitro Diagnostic (IVD) Regulations (3)
RA 696-C: Clinical and Performance Evaluation Reports for Medical Devices and IVD (1)
RA 696-D: Drug and Biologic Clinical Trial Management (1)
RA 696-E: Global Pharmacovigilance (2)
RA 696-F: Human Cell and Tissue (HCT/P) Product Regulations (2)
RA 696-G: Medical Device and IVD Clinical Trial Management (1)
RA 696-H: Oncology Drug Development (1)
RA 696-I: Statistics for Regulatory Affairs (1)
RA 701: Regulatory Intelligence/Regulatory Strategy (2)
RA 702: Pre-Approval Inspections (1)
RA 703: Introduction to Electronic Submissions (3)
RA 705: Project Planning for the Biomedical Industries (3)
RA 761: Drug/Device Product Development and Regulation in Europe and the US (1)
RA 772: Post-Approval Activities, Including Advertising, Promotion and Labeling (3)
RA 778: Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices (3)
Note that RA 773 or RA 774 may also be taken as an elective, if not taken as a required course.