»Master of Science in Regulatory Affairs (pending approval)

Program Highlights:

Two program tracks: Biopharmaceutical and Medical Devices
Part-time program options available for working professionals.
Located near biomedical, biotech and pharmaceutical companies and other job opportunities in Irvine, California.
Program covers the steps required to bring a medical product to market, both in the U.S. and around the globe.
Graduate courses address critical regulatory issues affecting all stages and processes in regulatory affairs.

Why Choose CUSP?

CUSP will provide students with a solid foundation in an integrated and interdisciplinary program within the regulatoryaffairs science and practice that combines:

A comprehensive education and training to include strong foundational knowledge, current practices andethics related to regulatory affairs.
Leadership, innovation and entrepreneurship in patient regulatory affairs through didactic course work, simulation and active-learning internships

Course work and simulation that broadens the trainees’ background to enhance career opportunities in regulatory affairs
The School of Pharmacy's location in Irvine, Orange County, CA, provides unique opportunities for students to network with nearby medical device and pharmaceutical companieshealth care organizations.Orange County is a hub for the medical device and pharmaceutical industry, and health care organizations. Orange County is the 1st US county by the number of employees and 2nd by the number of medical equipment and supplies manufacturing establishments (US Bureau of Labor Statistics). There is a substantial number of regulatory affairs positions and job openings in Orange, California and the US
Ranked #121 among 399 top-tier universities in the U.S. according to U.S. News & World Report, Chapman offers students personalized educational opportunities and a world-class faculty.

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The Master of Science in Regulatory Affairs (MSRA) degree requires completion of at least 30 credits. These include 18 credits of core courses, at least 9 credits of elective courses, and 3 credits of thesis or capstone project.

The MSRA program has two tracks: Biopharmaceutical and Medical Device

A program of study is developed individually in consultation with the student's mentor and is designed to ensure expertise in the student’s principal field. This will present students with the opportunity, under the supervision of the program advisor, to tailor their academic program to prepare them for the career path of their choice.

Biopharmaceutical Track

Core Courses (18 credits)
PHS 625	US Regulatory Framework. FDA Regulatory Pathways and Options,	3
PHS 633	Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation	3
PHS 635	Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements	3
PHS 636	US New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations	3
PHS 637	Biomedical Products Marketing, Pricing and Reimbursement	3
PHS 640	US Nonclinical and Clinical Regulation of Biomedical Products	3
Elective Courses (minimum 9 credits)
PHS 634	Global Regulatory Affairs	3
PHS 638	Medical Devices Applications, Software and Digital Health Applications: Quality Assurance and Post-Marketing Requirements	3
PHS 639	Medical Devices Applications, Software and Digital Health Applications: Pre-Marketing Regulation	3
PHS 602	Drug Discovery and Development	3
PHS 612	Advanced Principles of Drug Action	4
PHS 614	Biologics	2
PHS 615	Pharmacogenomics and Pharmacogenetics	2
PHS 621	Introduction to Pharmaceutical Manufacturing Process	3
PHS 631	Medical Diagnostics	3
PHS 632	Medical Devices	3
PHS 651	Quality System for Development and Manufacturing Drugs	3
PHS 661	Biomedical Market Access	3
PHS 662	Economic Evaluation of Health Care Services and Products	3
PHS 690	Internship	3
PHS 701	Research	1-3
PHS 702	Research Rotations	1
Thesis or Non-Thesis Option (3 credits) One of the following
PHS 696	Capstone	3
PHS 698	Thesis	3

Medical Device Track

Core Courses (18 credits)
PHS 625	US Regulatory Framework. FDA Regulatory Pathways and Options	3
PHS 634	Global Regulatory Affairs	3
PHS 637	Biomedical Products Marketing, Pricing and Reimbursement	3
PHS 638	Medical Devices Applications, Software and Digital Health Applications: Quality Assurance and Post-Marketing Requirements	3
PHS 639	Medical Devices Applications, Software and Digital Health Applications: Pre-Marketing Regulation	3
PHS 640	US Nonclinical and Clinical Regulation of Biomedical Products
Elective Courses (minimum 9 credits)
PHS 633	Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation	3
PHS 635	Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements	3
PHS 636	US New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations	3
PHS 602	Drug Discovery and Development	3
PHS 612	Advanced Principles of Drug Action	4
PHS 614	Biologics	2
PHS 615	Pharmacogenomics and Pharmacogenetics	2
PHS 621	Introduction to Pharmaceutical Manufacturing Process	3
PHS 631	Medical Diagnostics	3
PHS 632	Medical Devices	3
PHS 651	Quality System for Development and Manufacturing Drugs	3
PHS 661	Biomedical Market Access	3
PHS 662	Economic Evaluation of Health Care Services and Products	3
PHS 690	Internship	3
PHS 701	Research	1-3
PHS 702	Research Methods	1
Thesis or Non-Thesis Option (3 credits) One of the following
PHS 696	Capstone	3
PHS 698	Thesis	3

M.S. in Regulatory Affairs Program Learning Outcomes

Expresses foundational knowledge of the elements of the regulatory affairs sciences, including current research literature, policies and procedures, and methodology.
Understands regulatory affairs sciences by exploring and applying new ideas to current research.
Effectively communicate scientific principles, ideas, and research results with different audiences at an appropriate level.

»Master of Science in Regulatory Affairs (pending approval)

Program Highlights:

Why Choose CUSP?

Curriculum

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