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)
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 (4)
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. Possible offerings include:
- Regulatory Intelligence/Strategy (2)Regulatory intelligence involves gathering, monitoring, analyzing, and communicating regulatory information. This intelligence shapes regulatory strategy for product development and submission routes. This course develops the skills of regulatory affairs professionals to prepare and use regulatory intelligence to develop regulatory strategy recommendations.
- GXP Audits (1)GXP audits are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course familiarizes students with GXP audit activities and helps regulatory affairs professionals develop the skills to participate in the preparation, hosting, and follow-up to GXP audits.
- Pre-Approval Inspections (1)Students learn the requirements for hosting successful US FDA Pre-Approval Inspections (PAI) for small and large molecules, how to effectively interpret and apply current Good Manufacturing Practices (cGMPs), and the differences between FDA and EU requirements for the manufacture and control of pharmaceuticals.
RA 705: Project Planning for the Biomedical Industries (3)
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.