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.

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.

Total program cost is approximately $33,150.

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 should email regsci@sdsu.edu.

Courses

2018 Fall2019 Spring2019 Summer
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.

Course Date(s)

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Instructors
Norma J Schafer
2019 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 18 - May 19
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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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Instructors
Linn Bekins, Rita Tomlin
R A 0696.01 Introduction to Electronic Submissions

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.

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R A 0696.02 Pre-Approval Inspections

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.

Course Date(s)

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Instructors
Kadambi A Ajit-Simh
R A 0696.03 Regulatory Intelligence/Strategy

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.

Course Date(s)

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Instructors
Mary E Wilhelm
R A 0705 Project Planning for the Biomedical Industry

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.)

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R A 0750 Leadership for Change and Continuous Improvement

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.

Course Date(s)

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Instructors
Lorah Bodie
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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Instructors
Kadambi A Ajit-Simh
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.)

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Instructors
Kimberly A Walker
2019 Spring
R A 0774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices

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.)

Course Date(s)
March 18 - May 19
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Instructors
Norma J Schafer
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
R A 0778 Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices

Review of requirements, procedures, controls, and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices.

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R A 0779 International Regulatory Affairs

International medical device regulations pertaining to pharmaceuticals, biologics, and devices. Emphasis on European union and other appropriate areas of the world.

Course Date(s)

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Instructors
Gautam Maitra
2019 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 18 - May 19
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Instructors
Darrel Moellendorf
R A 0783 Effective Communication for Life Science Professionals

Written, oral, and interpersonal communication strategies for the business environment with emphasis on regulatory affairs.

Course Date(s)

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Instructors
Mary E Wilhelm, Gretchen N Vik
2019 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 14 - May 19
January 14 - May 19
January 14 - May 19
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Instructors
Lorah Bodie
2019 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 14 - May 19
January 14 - May 19
January 14 - May 19
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Instructors
Lorah Bodie