RAPS releases updated Regulatory Competency Framework

RAPS AnnouncementsRAPS AnnouncementsRAPSRAPS' Latest | 30 November 2021 |  By 

RAPS today announced the release of its updated Regulatory Competency Framework, describing the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to regulatory professionals in multiple healthcare product sectors, including pharmaceuticals, medical devices and biotech, and is useful to individual professionals, hiring managers and organizations.

“The Regulatory Competency Framework is designed to be highly flexible, and may be customized, built upon and applied to many different career paths and workplaces,” said Thomas Hutchinson, MS, RAC, FRAPS, who served as chair of the committee that oversaw the framework’s development. “It can be used by regulatory professionals to identify the competencies they need to advance their careers, by companies to design training and professional development resources for their regulatory staffs, or by academics to plan and improve curriculum.”

In addition to being applicable to different product sectors, the framework can be applied to professionals working not only in regulated industry, but also to those in government, research, clinical and other settings. It is designed to be relevant to all regulatory systems and geographic regions around the world.
The framework breaks down regulatory competencies into clear, easy-to-understand statements, categorized into seven knowledge domains: leadership, ethics, business acumen, scientific and health concepts, product development and registration, regulatory framework and strategy, and postapproval/postmarket. Within each domain, the competency statements are further categorized by specific knowledge areas and professional levels.

The framework is the result of years of ongoing research and development with the guidance of RAPS members and volunteer experts. This iteration builds upon preceding versions and includes significant updates and improvements to the previous edition released in 2016.


© 2023 Regulatory Affairs Professionals Society.

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