The Center for Bio/Pharmaceutical and Biodevice Development at San Diego State University provides education and training that enhance the professional excellence and career opportunities of scientists in the pharmaceutical, biotechnology and medical device industries. Programs and courses are designed to meet the continuing education needs of those with a degree in the chemical, biological or engineering sciences who are already employed in these industries. A primary objective is for students to establish a foundation of basic knowledge with a practical understanding for application to effectively address the real world challenges encountered during the development, manufacture and commercialization of FDA regulated therapeutic and medical device products. All of the Center's courses are available through distance learning as 10 week special sessions and designed to afford students a high degree of flexibility in integrating their studies with their professional responsibilities and other commitments.
Two years after being established, the Center introduced its first masters degree program, the Master of Science in Regulatory Affairs in September of 1999. With the considerable expansion of FDA authority since the 1970's to regulate the development and manufacturing activities for therapeutic and medical device products, an industry need for ongoing education and training in regulatory affairs has evolved. The regulatory affairs degree program prepares students to understand, address and effectively communicate to others the many regulatory requirements enforced by the U.S. Food and Drug Administration and other regulatory agencies that pertain to the development, testing, manufacture and commercial distribution of therapeutic and medical device products. Experienced industry professionals serve as course instructors and program advisors to better ensure courses are current with the constantly changing regulations and that they address the knowledge and practical understanding necessary for a high level of industry professional competency.
As an alternative to the full degree program, the Center also offers an advanced certificate in Regulatory Affairs. An advanced certificate may be earned by successfully completing a core subset of courses from the degree program.