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M.S. Regulatory Science Program
Students must complete 36 units to graduate from the MS program. A typical
graduate course is 3 units. Typically students take a minimum of 30 units
of coursework and complete a 6-unit internship/research project. Students
with experience in industry may be allowed to substitute six units of
additional coursework in lieu of the internship component with the approval
of the academic committee. Or, they can complete the research component
in their workplace with permission of the program committee. Unfortunately,
we cannot give you credit for your past work experience.
It is recognized
that students will have diverse backgrounds with differing levels of preparation
in fields relevant to the program under study. However, 8 courses from
a core of seven focus areas will normally form the base of the program
(Table 1). Additional courses are selected from a list of recommended
choices (Table 2) or any other applicable course can be taken (student
must first get approval from their advisor). Students are strongly advised
to consult with the program coordinator when making all course selections.
Up to 12 graduate units of relevant USC coursework, or 8 graduate units
taken in a different university, can be taken prior to formal enrollment
in the graduate program. These courses can be credited to the requirements
of the graduate program with the permission of the Admissions/academic
committee.
It is not necessary to take the classes in any particular order but we
do strongly suggest that people without regulatory/clinical experience
start with MPTX 511 -"Introduction to Medical Product Regulation".
Required Coursework:
Introductory (1 of the following) |
| MPTX 511 |
Introduction to Medical Product Regulation |
3 units |
√ |
| BME 416 |
Development & Regulation of Medical Products |
3 units |
|
| |
| Advanced Regulatory (2 of the following) |
| MPTX 512 |
Regulation of Drugs and Biologics |
3 units |
√ |
| MPTX 513 |
Regulation of Medical Devices |
3 units |
√ |
MPTX 514
|
Regulation of Food and Dietary Supplements |
3 units |
|
| |
| Quality |
| MPTX 515 |
Quality Assurance |
3 units |
√ |
| |
| Clinical |
| MPTX 517 |
Structure and Management of Clinical Trials |
4 units |
√ |
| |
| Biostatistics |
| MPTX 522 |
Clinical Design Course |
3 units |
√ |
| |
| Law |
| MPTX 516 |
Medical Products and the Law |
3 units |
√ |
| |
| Business (1 of following) |
| RSCI 601 |
Biomedical Commerce |
4 units |
√ |
| BAEP 551 |
Introduction to New ventures |
3 units |
|
| BAEP 552 |
Cases in Feasibility Analysis |
3 units |
| BAEP 556 |
Technology Feasibility |
3 units |
|
| BEAP 557 |
Technology Commercialization |
3 units |
|
| |
| Internship* |
| MPTX 630 |
Directed Field Research Project |
6 units |
√ |
| Total units of required coursework |
32 units |
|
| Optional Courses offered through Regulatory Science Program |
| MPTX 518 |
Medical Writing |
3 units |
| MPTX 519 |
International Approaches to Regulation |
3 units |
| RSCI 520 |
Risk Management |
2 units |
| RSCI 521 |
Seminar in Regulatory Science |
1 unit |
| MPTX 524 |
Food Science and Technology |
3 units |
| RSCI 525 |
Introduction to Drug and Food Toxicology |
3 units |
| MPTX 526 |
Chemistry Manufacturing Control |
3 units |
| RSCI 527 |
Medical Product Safety |
3 units |
| RSCI 528 |
Safety in Health Care Enviornment |
3 units |
| RSCI 529 |
Risk Management Tools and Techniques |
3 units |
| MPTX 530 |
Translational Medicine: An Overview |
2 units |
| MPTX 531 |
Drug Discovery |
4 units |
| MPTX 532 |
Early Stage Development |
3 units |
| MPTX 590 |
Directed Research |
1-6 units |
| MPTX 602 |
Science, Research, and Ethics |
2 units |
| |
| Total units for degree completion |
= 36 units |
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*International Students - Internship Options
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