School of Pharmacy
» Master of Science in Regulatory Affairs (pending approval)
Chapman University’s Master of Science in Regulatory Affairs (MSRA) is a four-semester program that provides advanced didactic education and experiential simulation training in an online format to help professionals advance as regulatory affairs experts and leaders.
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 regulatory affairs science and practice that combines:
- A comprehensive education and training to include strong foundational knowledge, current practices and ethics 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 companies health 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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Curriculum
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
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Core Courses (18 credits) |
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US Regulatory Framework. FDA Regulatory Pathways and Options, |
3 |
|
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Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation |
3 |
|
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Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements |
3 |
|
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US New Drug Applications, Abbreviated Drug Applications, and Over-the-Counter Pre-Marketing Regulations |
3 |
|
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Biomedical Products Marketing, Pricing and Reimbursement |
3 |
|
|
US Nonclinical and Clinical Regulation of Biomedical Products |
3 |
|
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Elective Courses (minimum 9 credits) |
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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 |
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PHS 702 |
Research Rotations |
1 |
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Thesis or Non-Thesis Option (3 credits) |
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Capstone |
3 |
|
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Thesis |
3 |
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Medical Device Track
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Core Courses (18 credits) |
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|
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) |
||
|
Biologic and Biosimilar License Applications (CDER and CBER): Pre-marketing Regulation |
3 |
|
|
Biologic and Biosimilar License Applications (CDER and CBER): Advanced Therapy Medicinal Products and Post-Marketing Requirements |
3 |
|
|
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) |
||
| PHS 696 |
Capstone |
3 |
|
Thesis |
3 |
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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.
CONTACT US
Office of Graduate Programs
gradpharmsci@chapman.edu
(714) 516-5497
Graduate Financial Aid
gradfinaid@chapman.edu
(714) 628-2730