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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. Just knowing the fundamentals of regulatory affairs is not enough to advance your career or secure a job in this industry. To become a regulatory affairs professional, training and education are essential.<br /><br />
Students must have completed a bachelor's degree before enrolling in courses they wish to transfer into the certificate or master's program.
SDSU offers a <strong>Master's Degree in Regulatory Affairs</strong> that focuses on good manufacturing processes, laws, and regulations mandated by major governmental regulatory agencies, specifically the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Topics related to discovery, development, testing, manufacturing, commercial distribution, and post-marketing surveillance are at the core of this program.<br /><br />
SDSU's Regulatory Affairs program provides students with detailed knowledge and understanding of current regulations and their practical application to the development and commercialization of pharmaceutical, biologic, veterinarian, and medical device products.<br /><br />
<strong>Innovative Curriculum, Flexible Online Delivery</strong><br />
The M.S. in Regulatory Affairs is a program offered by SDSU's College of Sciences in partnership with the College of Extended Studies.
<li>This program concentrates on the creation and implementation of innovative university curricula and training programs that respond to and promote the continued development and growth of the pharmaceutical, biotechnology, and biodevice industries.</li>
<li>Courses are taught online to provide the flexibility necessary for the student's other professional and personal commitments.</li>
<li>Students are normally enrolled in no more than two online courses at a time.</li>
Fees for the courses in this program include unlimited access to the SDSU library databases and resources.<br /><br />
<strong>Textbook Required:</strong> Textbook/course material information is available at <a href="http://regsci.sdsu.edu/course-materials/" target="_blank">regsci.sdsu.edu/course-materials</a>.<br /><br />
<strong>For more information visit <a href="http://regsci.sdsu.edu/" target="_blank">regsci.sdsu.edu</a> or call (619) 594-6030.</strong><br /><br />
In order to earn an advanced certificate or master's degree, you must apply and be admitted to SDSU. You may not take more than three units prior to being officially admitted into the advanced certificate, and no more than 12 units prior to the master’s degree program if you wish to earn an official SDSU advanced certificate or degree. For more information, please contact the Division of Graduate Affairs at <a href="mailto:email@example.com">firstname.lastname@example.org</a>.edu or call (619) 594-5213.
Writing for development of a new drug or biologic. Emphasis on effective writing of project reviews, research, reports, protocols, and CTDs.
Regulatory Affairs 601.
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. (Offered only as a distance education course.)
Controlling and facilitating change. Traditional quality tools and process improvement methods applied to biotechnology industry to create strong relationships with management and peers, communicate financial returns from a quality initiative, and selling benefits in a consultative manner.
Regulatory Affairs 602.
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. (Offered only as a distance education course.)
Review of requirements, procedures, controls, and documentation for quality control and assurance in the manufacture and commercial distribution of drugs, biologics, and medical devices. (Offered only as a distance education course.)
International medical device regulations pertaining to pharmaceuticals, biologics, and devices. Emphasis on European union and other appropriate areas of the world. (Offered only as a distance education course.)
Written, oral, and interpersonal communication strategies for the business environment with emphasis on regulatory affairs. (Offered only as a distance education course.)
Research in the area of regulatory sciences. Maximum credit six units applicable to a master's degree.
Advancement to candidacy.
Individual Study. Maximum credit six units applicable to a master's degree.
Consent of staff; to be arranged with department chair and instructor.
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.
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. Offered only as a distance education course.
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.)
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.)
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.)
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. Offered only as a distance education course.
Interest form - http://www.ces.sdsu.edu/client/iw/forms/site/ra.html