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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:firstname.lastname@example.org">email@example.com</a>.edu or call (619) 594-5213.
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.
This course will provide an introduction to current and future elements of electronic submissions for drug, biologic, and device submissions to health authorities. Electronic Common Technical Document (eCTD) and eCopy format will be covered. The course includes software instruction and a practicum to give students the opportunity to create content, assign content to an XML backbone, hyperlink documents, and validate compliance.<br /><br />
<p>This course requires <a href="http://www.lorenz.cc/eSolutions/docuBridge-one/" target="_blank">docuBridge ONE</a> software from LORENZ that can be obtained from the <a href="http://www.shopaztecs.com/es" target="_blank">SDSU Bookstore</a> for a discounted price of $300. Note that this software is not compatible with Mac OS, and must be run on Microsoft Windows Vista or higher. At the end of the course, students may keep the software. Students will no longer be able to generate eCTDs, but they can apply a $300 credit towards the purchase of a full software license within 90 days of the course conclusion. In addition, the course requires Adobe Acrobat Pro, also available at student pricing through the SDSU Bookstore.
FDA and FTC rules and regulations governing advertising, promotion, and labeling for prescription drugs, biologics, medical devices, and over-the-counter drugs.
Regulatory Affairs 602.
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.)
Interest form - http://www.ces.sdsu.edu/client/iw/forms/site/ra.html