In the United States, biomedical products must gain regulatory approval from the Food and Drug Administration (FDA) not only for marketing and commercial sales, but also for product development and testing. Much of the product information submitted to the FDA for regulatory approvals is based on data collected from human clinical trials. One of the most critical workforce needs in the life sciences industry today is for human clinical trials managers, clinical research associates, clinical data coordinators and regulatory affairs managers. To help educate potential employees, the BayBio Institute has compiled titles and descriptions for jobs in clinical development and regulatory affairs. The CSU is addressing this need through certificate programs in clinical trials management and regulatory affairs that are designed to provide college graduates with the necessary knowledge and skills they need to succeed in entry-level positions or to advance their professional development.
Resources:
Association of Clinical Research Professionals (ACRP)
Society of Clinical Research Associates (SoCRA)
Regulatory Affairs Professionals Society (RAPS)
Orange County Regulatory Affairs (OCRA)
Regulatory Affairs Certificate Program (Online)
The California State University, East Bay Advanced Certificate in Regulatory Affairs is designed for professionals who serve or seek to serve in a regulatory affairs role in the pharmaceutical, biopharmaceutical or medical device industries.
Those who take advantage of the program will acquire a thorough knowledge of the laws and regulations mandated by the federal government, especially those of the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, commercialization and postmarking surveillance of pharmaceutical, biopharmaceutical and medical device products. Offered in collaboration with San Diego State University's Center for Bio/Pharmaceutical and Biodevice Development, the program's online-only format makes it convenient for busy professionals anywhere in the world, not just those who live or work in the San Francisco East Bay Area.
For more information contact: Janice Bruett Program Coordinator at janice.bruett@csueastbay.edu or (510) 885-2321 or visit the program website 
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Advanced Certificate in Regulatory Affairs (Online)
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.
For more information contact: (619) 594-6030 or visit program website .
Clinical Trials Design and Management
Individuals who pursue a Clinical Trials Design & Management certificate from San Francisco State University's College of Extended Learning are professionals, often with advanced degrees, working in science, health care, technology, or management. Enroll now to transition into your new career.
Students may complete a full certificate or simply take those courses which advance their own professional goals. The Program is designed to be flexible for working adults by offering evening or weekend courses.
For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or visit the program website .
