Growing regulatory demands require professionals to seek continual training


The biomedical industry is in constant flux with new technologies and regulations emerging and evolving. Because of that, regulatory professionals must continually update their skills and knowledge — or risk getting left behind.

To ensure these professionals are able to stay ahead of the regulatory curve, a wide variety of post-baccalaureate certificate programs teach regulatory professionals about new regulations as well as best practices.

These certificate programs are not just about staying current but also about getting ahead. According to a report by the Regulatory Affairs Professional Society (RAPS), an industry trade group, the pursuit of advanced education such as certificates is one of the strongest predictors for advancement within the field.

regaff.jpgThe need for continuing education is only going to increase in the regulatory field as the FDA is expected become more assertive in keeping up with vast amounts of innovative technology. Professionals now must be better prepared to understand every stage of product development, ensuring compliance in research, monitoring, clinical testing, submission, manufacturing, marketing and more.

Because increased regulation boosts demand for regulatory professionals, there is also a need for specialized certificates that help other life-science careers transition into this growing field. According to RAPS, more than 90 percent of those in the regulatory field got their start in other careers.

To meet the growing demand for various regulatory professional skill levels, UC San Diego Extension recently expanded its overall certificate offerings.

“Our goal with these specialized certificates is to make sure there are educational opportunities and certifications available at all stages in the professional life of a regulatory affairs professional,” said Hugo Villar, Ph.D, MBA, director of science and technology at UC San Diego Extension.

regsci.jpgFor entry-level or transitioning professionals needing to learn basic principles of compliance and regulatory affairs, Extension recently updated its Regulatory Affairs Essentials Specialized Certificate. Courses have been streamlined to provide an understanding of the FDA-imposed regulations pertinent to the pharmaceutical and biological industries. In addition, Extension offers a new specialized certificate in Advanced Studies in Regulatory Science, designed for practicing professionals who need to prove they are up-to-date within the regulatory environment, filling gaps of knowledge acquired in professional practice to update current credentials.

Laura Guy, an advisor to Extension and a consultant with Regulatory Liaisons, said the Advanced Studies certificate is unique because of its focus on experienced professionals.

“Different from other current educational offerings, the Advanced Studies in Regulatory Science curriculum provides higher-level courses for those of us with much practical experience,” she said.” As regulations evolve, each professional must actively stay knowledgeable of proposed and newly implemented laws, standards and FDA guidance documents.”

For more details about these programs, visit our Sciences Area of Interest, e-mail, or call (858) 534-9353.

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