Regulatory science professionals are in demand. A career in regulatory affairs can take many paths, e.g., clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, or chemistry manufacturing and controls. Students in SDSU's Master of Science, and Advanced Certificate in Regulatory Affairs programs build foundational knowledge on laws, regulations, and good manufacturing processes mandated by the Food and Drug Administration (FDA) and its international counterparts. Courses are delivered fully online as nine-week special sessions, designed to afford students a high degree of flexibility in integrating their studies with work and other commitments.

The Center for Regulatory Science is located in SDSU's College of Sciences. For program information visit regsci.sdsu.edu, where you can see the requirements for the master's degree and advanced certificate, course descriptions, and application information. To speak with a program specialist, call (619) 594-6030.

International students may pursue the degree from their home country or within the U.S. at the same tuition rate as local students. However, the Regulatory Science program does not sponsor F1 student visas.

Students can enroll in courses before being admitted to the University. Four courses (12 units) can be transferred into the RA master's program and one course (3 units) can be transferred into the RA advanced certificate program.

Master of Science in Regulatory Affairs

This WASC-accredited program focuses on laws, regulations, and good manufacturing processes mandated by regulatory agencies, such as the FDA.

Advanced Certificate in Regulatory Affairs

The Advanced Certificate is a four-course subset of the MS degree program. All courses are transferable to the MS degree.

Intellectual Property and Regulatory Affairs

This six-course certificate in partnership with the USD School of Law uses an interdisciplinary approach to translate discoveries into products.

Students enrolled in these programs will receive their registration links by email from the Regulatory Science department. Others interested in registering for these courses may contact the program coordinator at righelli@mail.sdsu.edu.

Core Courses

2018 Spring2018 Summer2018 Fall
2018 Spring
R A 0602 Food and Drug Law

Laws governing drug, biological, and medical device products. Discussion of Federal Food, Drug, and Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.

Course Date(s)
March 12 - May 13
$2,550
Instructors
Scott Harris
R A 0605 Medical/Scientific Writing for Life Science Professionals

Writing for development of a new drug or biologic. Emphasis on effective writing of project reviews, research, reports, protocols, and CTDs.

Course Date(s)

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Inquire
R A 0770 Current Good Manufacturing Practice

Current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records.

Course Date(s)

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Inquire
2018 Spring
R A 0773 Medical Device Regulations

Overview of laws and FDA regulations for medical devices, in vitro diagnostics, radiological devices, FDA jurisdiction, registration, listing, labeling requirements, classification, Investigational Device Exemptions (IDE), pre-market approval (PMA), and pre-market notification [510(k)]. (Offered only as a distance education course.)

Course Date(s)
March 12 - May 13
Register
Inquire
R A 0775 Clinical Trials: Issues in Design, Conduct, and Evaluation

Issues and requirements in design, conduct, and evaluation of clinical trials for new drugs, biologics, and medical devices. Introduction to biostatistics. (Offered only as a distance education course.)

Course Date(s)

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Instructors
Bernard D King
2018 Spring
R A 0781 Ethics for Life Science Professionals

Ethical issues confronting health care professionals. Moral positions concerning impact on laboratory animals, human subjects, patients, and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.

Course Date(s)
March 12 - May 13
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2018 Spring
R A 0797 Project/Thesis Research

Research in the area of regulatory sciences. Maximum credit six units applicable to a master's degree.

Course Date(s)
January 8 - May 13
January 8 - May 13
January 8 - May 13
$850
Instructors
Lorah Bodie
2018 Spring
R A 0798 Special Study: R A 798

Individual Study. Maximum credit six units applicable to a master's degree.

Course Date(s)
January 8 - May 13
January 8 - May 13
January 8 - May 13
Register
Inquire
Instructors
Lorah Bodie
R A 0601 Pharmaceutical, Biotechnology, and Medical Device Industries

Pharmaceutical, biotechnology, and medical device industries. Company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control, and marketing.

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Instructors
Norma J Schafer

Courses

2018 Spring2018 Summer2018 Fall