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The <strong>Advanced Certificate in Regulatory Affairs</strong> involves the completion of four required online courses,<em> RA 601, RA 602, RA 770</em>, and <em>RA 781</em>.
<li><em><strong>RA 601:</strong> The Pharmaceutical, Biotechnology, and Medical Device Industries</em> covers the various steps in the development process for pharmaceuticals, biologics, and medical devices, with an understanding of the regulatory impact on this process.</li>
<li><em><strong>RA 602:</strong> Introduction to Food and Drug Law</em> provides a basic knowledge of the laws and regulations governing these industries.</li>
<li><em><strong>RA 770:</strong> Current Good Manufacturing Practice General Concepts</em> covers the basic concepts of good manufacturing practices.</li>
<li><em><strong>RA 781:</strong> Practical Ethics for Health Care Professionals General Concepts</em> covers the ethical issues confronting health care professionals.</li>
All courses are offered online. Fees for the courses include unlimited access to the SDSU library databases and resources.<br /><br />
In order to enroll in this program, you must hold a baccalaureate degree from a regionally accredited institution. Courses taken before a baccalaureate degree is completed are not eligible for transfer into the certificate program.
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 />
SDSU offers an advanced certificate in regulatory affairs 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 />
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" target="_blank">email@example.com</a> or call (619) 594-5213.<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>
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.
Regulatory Affairs 601.
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.)
Regulatory Affairs 602.
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