GC in Regulatory and Clinical Affairs (RCA)

The USC Graduate Certificate in Regulatory and Clinical Affairs requires satisfactory completion of 12 units beyond the baccalaureate degree.

Required Courses

All of the courses offered by the Department of Regulatory and Quality Science can be taken either in-person or online (within the United States). Upon admission we will work with you to develop a course plan that fits your needs. You can find all course descriptions here.

Introductory Course (Choose 1 course)

MPTX 511: Introduction to Medical Product Regulation

RSCI 531: Industrial Approaches to Drug Discovery

RSCI 532: Early Stage Drug Development

Advanced Regulation (Choose 1 course)

MPTX 512: Regulation of Pharmaceutical & Biologic Products

MPTX 513: Regulation of Medical Devices & Diagnostics

MPTX 514: Regulation of Food & Dietary Supplements

Quality Assurance & Risk Management (Choose 1 course)

RSCI 508: Quality Assurance for Drugs & Biologics

RSCI 509: Quality Assurance, Medical Devices & Combination Products

MPTX 515: Quality Systems & Standards

RSCI 520: Introduction to Risk Management for Health Care Products


Any remaining units can be filled with elective coursework chosen from the courses offered by the Department of Regulatory and Quality Sciences.

Suggested Electives

MPTX 517: Structure & Management of Clinical Trials

MPTX 518: Writing Regulatory Drug Submissions

MPTX 522: Introduction to Clinical Trial Design & Statistics

MPTX 526: Chemistry Manufacturing and Controls

RSCI 525: Introduction to Drug & Food Toxicology

Graduation Requirements

In order to complete the Graduate Certificate in Regulatory and Clinical Affairs you must have met the following requirements:

  • At least 12 units of required and elective courses
  • Obtained a cumulative GPA of 3.0 or better
  • Maintain continuous enrollment during all fall and spring semesters
  • Complete the certificate within five years

Admission Requirements

Detailed admissions and application information can be found on the Graduate Certificate Admissions Page.