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When it comes to meeting Food and Drug Administration (FDA) requirements for their products, pharmaceutical, biologics, and medical device manufacturers are often challenged to maintain in-house staff with sufficient expertise in regulatory affairs. One reason for this difficulty has been the relative dearth of academic programs devoted to training individuals in regulatory affairs and the need to develop these experts through on-the-job training. There are relatively few academic programs focused on educating individuals about the regulatory requirements for medical products. One such offering is the Master of Science in Regulatory Affairs degree program developed by the Center for Bio/Pharmaceutical and Biodevice Development (CBBD) at San Diego State University (SDSU).1

Background

At the time that SDSU was contemplating the design of an M.S. degree program in regulatory affairs, only two such programs were available in the United States. Both of the universities offering these degrees were located on the East Coast, in the heart of the pharmaceutical industry, and both programs originated within existing departments of pharmacy. Such industry influences and departmental connections explained why the M.S. program in quality assurance and regulatory affairs at Temple University (Philadelphia, Pennsylvania) and the M.S. program in drug regulatory affairs at Long Island University (Brooklyn, New York) focused primarily on pharmaceuticals.2, 3

The influence of local industry also played a role in shaping SDSU's degree program, but with quite different results. SDSU is located in a county that is home to more than 350 companies involved in health care product R&D. In contrast to the overwhelming concentration of pharmaceutical companies found on the East Coast, San Diego County's health care product companies are more or less evenly distributed among all aspects of the health care spectrum, including pharmaceuticals, biologics/biotechnology, and medical device companies.

Many of the health care product companies in San Diego began life as small start-up ventures. Although such firms typically concentrated their early efforts on technology development and proof-of-concept testing, they recognized the need for regulatory affairs expertise. Hence, many of the region's companies were still in their early stages of development when they began to develop or hire staff with relevant training in regulatory affairs. It was within this milieu that the CBBD designed the curriculum for its M.S. degree program in regulatory affairs.

Curriculum and Faculty Development

To determine the shape of the program, CBBD staff conducted surveys among many of the health care product companies in the region. The results of the survey not only confirmed that there was a need for such a regulatory affairs program, but also helped to determine the thrusts that the program should take. To assist in developing the curriculum, SDSU hired two individuals with extensive experience in the health care R&D industry. They designed a curriculum to provide education in the laws and regulations that pertain to health care product manufacturers, and to consider the effects of such laws and regulations on areas of R&D with significant regulatory exposure.

One of the first steps taken by the program's director was to organize an advisory committee consisting of senior regulatory affairs professionals working at local pharmaceutical, biologics, and medical device companies. This advisory committee helped flesh out the content of each course and develop a syllabus for each one. Armed with these syllabi, the director recruited regulatory professionals to teach these courses, as well as to participate as guest lecturers. The advisory committee continues to advise the director on developing new courses and selecting potential candidates to teach these courses. The degree program was approved by the university at the end of March 1999, and the first courses for the program were launched in the fall of 1999.

The Program

SDSU's regulatory affairs program is a 40-unit degree curriculum that takes 21 to 24 months to complete. One of the required courses is an introduction to the pharmaceutical, biotechnology, and medical device industries, which provides an overview of the R&D process for each of these sectors. The program also requires students to take courses on food and drug law, good manufacturing practices, and investigational and marketing applications. Once students have completed the requisite coursework, they are required to complete a thesis or project report.

The elective courses in the curriculum are designed to expose students to further details about the regulatory impact on the R&D effort. These electives include courses on medical device regulations, clinical trials, quality control, validation, and postapproval activities. In addition, three business courses on organizational behavior, operations management, and communication strategies are included in the curriculum to highlight the importance of working and communicating effectively in a team-based atmosphere. A full listing of available courses may be found at the center's Web site.

Individual Courses and Distance Learning

For individuals interested in expanding their knowledge of regulatory affairs, but unable to commit the time and resources necessary to pursue a master's degree, SDSU also offers a certificate in regulatory affairs. CBBD offers courses from the regulatory affairs program through the SDSU College of Extended Studies, and individuals can enroll in these individual courses to expand their expertise and gain university credit.

CBBD has explored the possibility of making this program and its courses available throughout the California State University (CSU) system. After evaluating a number of options, CBBD decided to transform the local lecture courses to Internet-based online distance-learning presentations. Currently, all of the regulatory affairs courses are available online, and students from throughout the U.S. and Canada have successfully completed this online coursework.

Students and Graduates

The program was launched with 14 students but currently has more than 45 students enrolled. Most of the students enter the program as working professionals: approximately two-thirds come from the pharmaceutical, biologics, and medical device industries, while the remaining third are employed in contract research organizations and other scientific organizations. To date, 19 students have completed their M.S. degrees in regulatory affairs, including one student who came to the program from South Korea.

Conclusion

SDSU's program provides courses that teach not only the basics of regulatory requirements but also how FDA interprets and enforces its regulations. With the scope of the courses as well as the ability to extend the presentation of these courses online, our program offers individuals an opportunity to gain additional education in the regulatory aspects of health care research and development, regardless of their geographic location.

References

1. CBBD Home Page (San Diego, CA: San Diego State University, Center for Bio/Pharmaceutical and Biodevice Development); available from Internet: www.cbbd.sdsu.edu/regaffairs.

2. QA/RA Home Page (Philadelphia: Temple University School of Pharmacy, Graduate Program in Quality Assurance/Regulatory Affairs); available from Internet: www.temple.edu/pharmacy_QARA.

3. Division of Social and Administrative Sciences Home Page (Brooklyn, NY: Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences); available from Internet: www.liu.edu/cwis/pharmacy/phbut07/grad03.html.

Larry Gundersen, Ph.D., RAC, is director of regulatory affairs programs at San Diego State University in San Diego, California. He can be reached via lgunders@sciences.sdsu.edu.