Required Coursework

MS in Regulatory Science

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Students will complete a total of 36 units including 25 units of core courses and up to 10 units of electives, which may include an internship.

Core Courses

Introductory Regulation

MPTX 511: Introduction to Medical Product Regulation – 3 units

Advanced Regulation

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
MPTX 524: Introduction to Food Science & Technology – 3 units

Quality Assurance

RSCI 508: Quality Assurance for Drugs & Biologics – 3 units
RSCI 509: Quality Assurance, Medical Devices & Combination Products 3 – units
MPTX 515: Quality Assurance – 3 units

Clinical Research

MPTX 517: Structure and Management of Clinical Trials – 4 units

Statistics

RSCI 507: Quality Systems and Statistical Process Control – 2 units
MPTX 522: Introduction to Clinical Trial Design & Statistics – 3 units

Medical Product Law

MPTX 516: Medical Products and the Law – 3 units

Business

RSCI 601: Biomedical Commerce – 4 units

Core courses required  for degree completion = 25 units

Internship

Students with industry experience generally would not pursue an internship and would take additional elective coursework. Domestic students without prior industry experience can take 2-6 units of internship while international students would enroll in it for 1 unit. (International Students see additional internship details below*)

Elective Courses 

RSCI 506: Auditing Principles
RSCI 520: Introduction to Risk Management for Health Care Products
RSCI 521: Seminars in Regulatory Science
RSCI 525: Introduction to Drug & Food Toxicology
RSCI 527: Medical Product Safety
RSCI 529: Application of Risk Management Tools & Techniques
RSCI 531: Industrial Approaches to Drug Discovery
RSCI 532: Early Stage Drug Development
RSCI 533: Safety Evaluation During Drug Development
RSCI 540: Analysis of Food and Dietary Supplement Regulations
RSCI 541: Drug Development, Reimbursement, and Marketing
RSCI 590: Directed Research
RSCI 596: Internship for Curricular Practical Training in Regulatory Science
RSCI 603: Managing Complex Projects
RSCI 606: Regulation of Emerging Technologies & Biological Products
MPTX 518: Writing Regulatory Drug Submissions
MPTX 519: Global Regulation of Medical Products
MPTX 522: Introduction to Clinical Trial Design & Statistics
MPTX 524: Introduction to Food Science and Technology
MPTX 526: Chemistry Manufacturing and Controls
MPTX 602: Science, Research and Ethics

Total units for degree completion = 36 units

*International Students – Internship Options
Due to recent visa issues, students may experience difficulties in finding internship opportunities in the United States during their MS in Regulatory Science (MSRS) studies. Individuals without permanent residence in the United States or those with limited written, verbal, or communication skills in English may find that they have trouble to secure an internship opportunity during the tenure of the program, especially if they are intending that the internship opportunity will lead to full‐time employment. International students wishing to gain internship experience must do this on an individual basis, and position the internship toward the end of their MSRS degree. While we are vigilant to find companies who are interested in providing internships, students should also be proactive in looking for paid or unpaid internships in an academic, clinical, or industry setting. Otherwise more coursework may be taken in lieu of the internship experience in order to meet degree conferral requirements. For further questions regarding the internship option please contact the program manager at regsci@usc.edu.