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 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.

Textbook/course material information is available at www.sdsubookstore.com/es; just use your five digit schedule number when selecting a course.

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. All courses are offered online.

In order to enroll in this program, you must hold a baccalaureate degree from a regionally accredited institution.

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

Textbook/course material information is available at www.sdsubookstore.com/es; just use your five digit schedule number when selecting a course.

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

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 9 units prior to being officially admitted into the advanced certificate or 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 gra@mail.sdsu.edu or call (619) 594-5213.

Tutorial for Registered Students
Students are strongly encouraged to complete the Introduction to Healthcare Product Regulation tutorial. Information about accessing this will be provided upon registration for the program. This online tutorial is self-paced and designed to be completed over a number of weeks. It is optional, but it provides important background information that will greatly benefit students as they begin their certificate courses.