Regulatory Science (DRSc)

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The Doctor of Regulatory Science program cultivates research, leadership and inquiry skills for advanced students in the emerging profession of global regulatory science. It is designed to produce graduates with expertise in strategic management, policy development and research assessment who can play leadership roles in the public sector, academia and the medical products industry. Participants in this program will take a set of interdependent courses that extend from a strong core of basic regulatory science course work and additionally focus on three main areas — global product strategy, product lifecycle strategy, and project and personnel management. After students have completed foundational course work, they will participate as a cohort that typically has a two-year cycle of classes and an additional year of dissertation research. The program has been designed to meet the needs of individuals who are already working full-time outside of the university. The doctoral degree will be administered by the School of Pharmacy.

Admission

The program is designed for individuals with strong professional experience and demonstrated intellectual and leadership capabilities. Applicants are expected to have a GPA of 3.0 on university-level course work and ten or more years of professional experience. Admission requirements include university transcripts, a resume, at least three letters of reference, and a one-page personal statement that outlines the background and goals of the applicant. Students are encouraged even at this early stage to identify areas in which they are interested in conducting research. Additional requirements for international students are outlined by university regulations under Admission of International Students. Students are not required to provide GRE scores unless indicated by the program director.

Students with an appropriate graduate or professional degree may use some previous graduate courses as transfer units toward the overall credit requirements of the Doctor of Regulatory Science program with the approval of the program director and under the normal rules of the university. Students who have graduated from the MS program in Regulatory Science can apply all of the previously taken course work toward the doctoral degree. Students with graduate degrees from outside of the regulatory science program are required to take a minimum of 32 units of course work and 4 units of dissertation research to complete the requirements for graduation. The course work requirements will be determined on an individual basis in consultation with the program director and participant’s advisers.

Curriculum Requirements

The Doctor of Regulatory Science is administered by the School of Pharmacy. It requires participants to complete 64 units that include the following elements:

Requirements

Foundation courses 15 Units
Product lifecycle strategy 8 Units
Global strategy 8 Units
Project/personnel management 8 Units
Research methods 4 Units
Dissertation 4 Units

Additional Requirements

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.

Foundation Courses

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.

Research Methods

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.

Doctoral Dissertation

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.