Program Requirements

1. Baccalaureate or graduate degree in an appropriate discipline. M.S. student should have a minimum grade point average of 3.0. You must provide transcripts of colleges/universities attended. Applicants with foreign transcripts must submit an official language transcript as well as a certified translation.

2. Qualifying scores on the GRE of 1000 (verbal and quantitative), or equivalent performance on some other standardized test (ie, MCAT, GMAT). This requirement is for M.S. students only.

3. Proficiency with the English language and excellent communication skills.

4. Two letters of reference.

5. One page letter statement of purpose- (ie. "Why do you want to take the degree or certificate program in Regulatory Science?", "What attributes do you have that distinguish you as a good candidate for our program?").This is a very important part of your application.

 

 

What does the program involve?

Limited Student

Students interested in taking a course or two as a limited enrolled student before applying to the certificate or M.S. program should contact the program for further information. Limited enrolled students are allowed to take up to 12 units before they have to apply to the program. Be reminded that students interested in the certificate option must apply before they finish their last course in the certificate program. Full tuition amount is required under this status. Click here for more specific information.

 

Certificate Program

The program now offers “Certificates in Safety” which is a family of graduate certificate programs at USC. These accredited offerings are designed to develop specialists with an unusually high level of competence in high-demand fields of medical products development.  Three certificates are offered. 

The program is designed for working professionals who wish to take one or two courses per term in convenient weekend or distance formats. Each program requires the completion of 12 units of study in courses 2-4 units in length.  More information on these programs can be obtained from the Regulatory Science program. Click here for more specific information.

 

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



--------------------------------------------------------------------------------

*International Students - Internship Options