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. For any additional questions, call (619) 594-0845.
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.
This WASC-accredited program focuses on laws, regulations, and good manufacturing processes mandated by regulatory agencies, such as the FDA.
Total program cost is approximately $33,150.
The Advanced Certificate is a four-course subset of the MS degree program. All courses are transferable to the MS degree.
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 should email email@example.com.
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.
January 14 - March 17
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.
October 15 - December 16
March 18 - May 19
Current issues and topics in regulatory affairs evaluated and discussed. Recent developments and changes in selected areas of regulatory affairs presented by faculty and industry professionals. May be repeated with new content. Maximum credit six units applicable to the master of science degree in regulatory affairs.
Students learn the requirements for hosting successful US FDA Pre-Approval Inspections (PAI) for small and large molecules, how to effectively interpret and apply current Good Manufacturing Practices (cGMPs), and the differences between FDA and EU requirements for the manufacture and control of pharmaceuticals.
Regulatory intelligence involves gathering, monitoring, analyzing, and communicating regulatory information. This intelligence shapes regulatory strategy for product development and submission routes. This course develops the skills of regulatory affairs professionals to prepare and use regulatory intelligence to develop regulatory strategy recommendations.
Complexity of biomedical product development. Projects and strategies for effectively planning and managing them. Understanding and utilization of management and planning strategies as applied to these biomedical product development projects. Strategies for planning, scheduling, and effective management of regulatory affairs activities and related tasks associated with development of a biomedical product. (Offered only as a distance education course.)
Change management as it relates to strategic planning and quality improvement to increase competitive advantage. Controlling and facilitating change utilizing quality and statistical tools and concepts, and process improvement methods, as applied to management and leadership challenges and production and manufacturing issues.
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.
January 14 - March 17
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.)
Development and informational content for investigational new drug applications (IND), investigational device exemptions (IDE), new drug applications (NDA), product license applications (PLA), and biologics license applications (BLA) for FDA review. (Offered only as a distance education course.)
March 18 - May 19
Review of requirements, procedures, controls, and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices.
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.
March 18 - May 19