Additional elective course work will be selected in consultation with the program advisers according to the areas of intended specialization of the participant in order to meet the credit requirements of the program. Typically foundational courses and some electives will be taken in the first two years of the program. Advanced courses in product lifecycle strategy, global strategy and project/personnel management will normally be taken by the doctoral cohort of students during the third and fourth years of the program. Dissertation planning and research will typically commence in the third year of the program, and extend until the successful completion of the dissertation.
Fifteen or more units of foundation courses may be taken as part of the master’s program in regulatory science, or with prior approval, from another graduate program with similar objectives. Required foundational courses normally include: MPTX 511 Introduction to Medical Product Regulation ; two from MPTX 512 Regulation of Pharmaceutical and Biological Products , MPTX 513 Regulation of Medical Devices and Diagnostics , MPTX 514 Regulation of Food and Dietary Supplements ; MPTX 515 Quality Systems and Standards , MPTX 516 Medical Products and the Law ; MPTX 517 Structure and Management of Clinical Trials . Other courses may be substituted after the participant’s background preparation has been considered.
Product Lifecycle Strategy
Eight or more units of course work related to product lifecycle management, from discovery to commercialization, will be drawn from a broad list of courses offered in regulatory science or through the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics and Policy. Included in this list are: PMEP 538 Pharmaceutical Economics ; PMEP 539 Economic Assessment of Medical Care ; RSCI 601 Biomedical Commerce . Other courses may also be considered in consultation with the supervisors and program director. Students are also encouraged to take courses outside the School of Pharmacy when more specialized courses fit their professional research or development plans.
Global Regulatory Strategy and Policy
Eight or more units of course work related to global regulatory strategy could include some of the following courses: MPTX 519 Global Regulation of Medical Products ; PPD 571 International Public Policy and Management Seminar ; RSCI 604 Regulatory Strategy in Asia ; RSCI 608 Regulatory Strategy in Europe and the Americas .
Project and Personnel Management
Eight or more units of relevant course work should typically include: MPTX 602 Science, Research and Ethics ; RSCI 603 Managing Complex Projects ; RSCI 605 Managing Organizations and Human Resources . Graduate courses in other university departments or schools can be substituted with the approval of the program director.
Participants will typically take PMEP 509 Research Design or MPTX 522 Introduction to Clinical Trial Design and Statistics .
Student Progress and Assessments
In the third year, students are expected to identify a pair of advisers including one USC faculty member and one adviser from industry or the private sector. Students are typically placed in study groups of three or four whose dissertation interests are most similar and whose collective supervisors will oversee their academic and research progress. This committee will form the dissertation committee.
At the completion of the foundational course work, students will undergo a competency review that will include considerations of academic progress. Students are expected to maintain a GPA of 3.0 and will be required to pass a written examination designed to assure the professional competence of the student prior to advancing further in the program. Students who do not pass this preliminary review, administered prior to entering the dissertation and advanced course work phase of the program, will be notified of dismissal from the program in writing by the associate dean for graduate studies in the School of Pharmacy.
Students must enroll in RSCI 794a , RSCI 794b , RSCI 794c , RSCI 794d , RSCI 794z for at least two terms, during which time they will develop a dissertation proposal and conduct the necessary research and analysis in collaboration with the supervisory team. The dissertation committee will approve the thesis plan and monitor its progress. Each student will be required to produce and defend an independent dissertation as a requirement for graduation. A maximum of 6 dissertation units can be applied to satisfy the degree requirement, but students should register for the dissertation units in each term subsequent to the completion of their course work requirements. Institutional Review Board approval is required for all human studies.