Medical Device Link.

Originally Published IVD Technology April 2002

Regulations & Standards

Academic training for regulatory affairs professionals

Larry Gundersen and Laura Guy

One reason for this difficulty has been the relative dearth of academic programs devoted to training individuals in regulatory affairs. It is only recently that such academic programs focused on educating individuals about the regulatory requirements for medical products—including IVDs—have become available. One such offering is the master of science in regulatory affairs program recently developed by the Center for Bio/Pharmaceutical and Biodevice Development (CBBD) at San Diego State University (SDSU; San Diego).¹

Background

At the time that SDSU was contemplating the design of an MS 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 explain why the MS program in quality assurance and regulatory affairs at Temple University (Philadelphia) and the MS program in drug regulatory affairs at Long Island University (Brooklyn, NY) focus almost exclusively on pharmaceuticals.^2,3 Neither program offers significant opportunities for regulatory affairs training that would be of relevance to individuals working at medical device companies.

The influence of local industry has 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 healthcare product R&D. In contrast to the overwhelming concentration of pharmaceutical companies found on the East Coast, however, San Diego County's healthcare product companies are more or less evenly distributed among all aspects of the healthcare spectrum. Companies in the region include many pharmaceutical firms, a significant concentration of biologics and biotechnology companies, and a large number of medical device firms with specialties in virtually every sector—including IVDs. Among the better-known IVD companies in the region are Gen-Probe, Hybritech, and Biosite Diagnostics.

Also in contrast to the East Coast concentration of large, established pharmaceutical firms, many of the healthcare product companies in San Diego began life as small start-up ventures. Although such firms typically concentrate their early efforts on technology development and proof-of-concept testing, the need for regulatory affairs expertise is often not long in coming. Hence, many of the region's companies were still at an early stage of their development when they began to recognize their need to develop or hire staff with relevant training in regulatory affairs.

It was within this milieu that the CBBD designed the curriculum for its MS degree program in regulatory affairs.

Curriculum and Faculty Development

To determine the shape that the program should take, CBBD staff conducted surveys among many of the healthcare 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. Again, in contrast to the overwhelming emphasis on pharmaceuticals found in the East Coast programs, the survey results indicated that the local need was for a curriculum that would provide broad coverage of regulatory affairs relevant to firms in medical devices, pharmaceuticals, and biologics—and sufficient depth in each area to permit graduates to develop a strong area of concentration.

To assist in developing the curriculum, SDSU hired an individual with extensive experience in the healthcare R&D industry. The curriculum was designed to provide education in the laws and regulations that pertain to healthcare product manufacturers, and to consider the effects of such laws and regulations on areas of R&D with significant regulatory exposure. While this curriculum outline was progressing through the university's approval process, SDSU hired another individual with more than 25 years of experience in regulatory affairs as the director of regulatory affairs programs.

One of the first steps taken by the new director was to organize an advisory committee consisting of senior regulatory affairs professionals working at local medical device, pharmaceutical, and biologics companies. This advisory committee helped flesh out the content of each course and developed a syllabus for each one. Armed with these syllabi, the director recruited regulatory professionals to teach each of these courses, as well as to appear as guest lecturers. The advisory committee continues to advise the director on developing new courses and selecting potential candidates to teach these new 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 21–24 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 titles of the required courses indicate that the program covers R&D in all the major healthcare sectors, including medical devices (see sidebar). At least one course focuses specifically on medical devices and includes significant information about IVDs.

Because the scope of medical device R&D is so broad and complex, often requiring innovative regulatory approaches, an elective course on medical device regulations was designed to explore this subject in greater depth. In this course, the students are divided into small groups, with each group assigned to a different medical device or diagnostic project. The groups create a development plan and timeline for their project, and twice during the course each group is given either a positive or negative piece of news that requires them to reevaluate their plan. During the final course session, each group presents its final plan, and the instructor and other students critique the regulatory strategy that the team adopted.

The other 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 clinical trials, quality control, validation, and postapproval activities. In addition, recognizing the importance of working and communicating effectively in a team-based atmosphere, three business courses on organizational behavior, operations management, and communication strategies are included in the curriculum.

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. The CBBD offers courses from the regulatory affairs program through the SDSU College of Extended Studies, and individuals can enroll in these courses to expand their expertise and gain university credit. By completing the first three basic courses of the curriculum, individuals can qualify for a certificate in regulatory affairs. In addition, such extension classes can also serve as refresher courses for industry veterans who need an update on recent developments in regulatory affairs.

The 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, the CBBD decided to transform the local lecture courses to Internet-based on-line distance-learning presentations. Currently, about half of the regulatory affairs courses are available on-line, and students who are enrolled through CSU Hayward have completed some of the courses. Individuals from Ft. Worth, TX, and Toronto, Canada, have also enrolled in the on-line courses.

Students and Graduates

The program was launched with 14 students, and currently has more than 25 enrolled students. Most of the students come into the program as working professionals: approximately one-third come from the medical device arena, another third from the pharmaceutical and biologics industry, and the remaining third are employed in contract research organizations (CROs) and other scientific organizations. Of those students who come from the medical device industry, about half of them originated from the IVD sector. Eight of the original 14 students graduated in May 2001, and another group of students is working on their final theses or projects, and planning to graduate in May 2002.

Conclusion

Until recently, there has never been a program that offered training on regulatory affairs in the area of medical devices and IVDs. SDSU's program has changed all that by providing 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 many of the courses on-line, this program offers individuals an opportunity to gain additional education in the regulatory aspects of this business.

References

1. CBBD Home Page [on-line] (San Diego, CA: San Diego State University, Center for Bio/Pharmaceutical and Biodevice Development, 2002); available from Internet: http://www.cbbd.sdsu.edu/regaffairs/.

2. QA/RA Home Page [on-line] (Philadelphia: Temple University School of Pharmacy, Graduate Program in Quality Assurance/Regulatory Affairs, 2002) available from Internet: http://www.temple.edu/pharmacy_QARA/.

3. Division of Social and Administrative Sciences Home Page [on-line] (Brooklyn, NY: Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, 2002); available from Internet: http://www.liu.edu/cwis/pharmacy/phbut07/grad03.html.

Larry Gundersen, PhD, RAC, is director of the regulatory affairs programs at San Diego State University (San Diego). He can be reached via lgunders@sciences.sdsu.edu. Laura Guy, MS, RAC, graduated from the program and is currently manager of regulatory affairs and quality assurance at Santarus Inc. (San Diego). She can be reached via lguy@santarus.com.

Copyright ©2002 IVD Technology