Offered by SDSU’s College of Extended Studies and The Center for Bio/Pharmaceutical and Biodevice Development (CBBD).

CBBD 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.

The degree focuses on laws and regulations mandated by the Federal government, especially the Food and Drug Administration, related to discovery, development, testing, and manufacture of products for commercial distribution, and post-marketing surveillance. The degree program will provide students with detailed knowledge and understanding of current regulations and their practical application to the development and commercialization of drugs, biologics, and medical device products.

Courses usually are taught online to provide the flexibility necessary for the student's other professional and personal commitments. Students are normally enrolled in no more than two online courses at a time.

Please note: Registrations after the first day of class and for 799A require department approval. For approval call (619) 594-6030.

If you have completed the Advanced Certificate in Regulatory Affairs and you plan to continue with the Master of Science in Regulatory Affairs, you must apply and be accepted to SDSU before taking any more courses. You may not take more than 12 units prior to being officially accepted into the SDSU MA program. For more information, please contact the Division of Graduate Affairs at gra@mail.sdsu.edu or call (619) 594-5213.

For more information call (619) 594-6030 or see www.cbbd.sdsu.edu

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The certificate involves the completion of four required courses, RA 601, RA 602, RA 770, and RA 781. RA 601 covers the various steps in the development process for pharmaceuticals, biologics, and medical devices, with an understanding of the regulatory impact on this process. RA 602 provides a basic knowledge of the laws and regulations governing these industries. RA 770 covers the basic concepts of good manufacturing practices. RA 781 covers the ethical issues confronting health care professionals.

Please note: Registrations after the first day of class and for 799A require department approval. For approval call (619) 594-6030.

For more information call (619) 594-6030 or see www.cbbd.sdsu.edu