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.
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.
Clinical Trials Project Management Certificate (Online)
The certificate is graduate level, 12-unit, cohort-based ONLINE credit program. It is designed to meet the high demand for project management personnel for human clinical trials involving medical devices, in vitro diagnostics, biologics, pharmaceuticals and combination products, with the focus on managing biomedical product development for FDA approval.
The certificate program is ideal for professionals interested in pursuing a management career in clinical trials. It is designed to help clinical research association coordinators, health care and allied health professionals and professionals involved in the development of a medical product to refine their skills or expand their knowledge. The online format allows for a more flexible schedule for those already in the workforce. Even though the class takes place outside of the traditional classroom, the program offers on real-world experiences involving team projects and case studies.
The four required courses incorporate several overall themes: project management, ethics in biomedical product development, data management and global regulatory affairs.
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.