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Promoting excellence in the regulatory a affairs profession: A competency framework
Abstract
In this article, we discuss the evolution of the Regulatory Affairs Competency Framework, and its significance. Our goal is to stimulate discussion about the current status of the profession and the knowledge, skills, and abilities that regulatory professionals need today, and in the future. As innovation occurs, it is important that regulatory professionals stay relevant and have the necessary skills and competencies to make substantive contributions to their organisations. We believe that this framework is an important contribution towards this goal. In addition, it offers guidance on the role of the regulatory professional in the delivery of safe, high quality, and accessible healthcare products for human and animal use to patients and consumers worldwide.
... However, the advancing globalization of the life-science field (Carroll & Blair, 2008), the opening of new emerging markets, and other factors increasingly require new professionals to be proficient not only in national but also in international regulations governing regulated products (Drago, Yap, & Ekmecki, 2016). This situation demands the targeted training of a new generation of professionals, as well as the further qualification of those already working in the regulatory affairs field (Drago, Alsbury, & Connolly, 2017). Candidates seeking to enroll in a regulatory affairs master's program are aware of these new demands in the workplace and are increasingly interested in a curriculum that includes an international perspective. ...
Aim/Purpose: This paper describes the regulatory affairs discipline as a useful case in the study of both inter- and transdisciplinary science and dynamics related to communication across multiple boundaries. We will 1) outline the process that led to the development of transnational competencies for regulatory affairs graduate education, 2) discuss how the process highlights the transdisciplinary character of regulatory affairs, 3) provide implications for how to communicate the influence of this characterization to future healthcare professionals, and 4) draw conclusions regarding how our lessons-learned might inform other programs of study.
Background: In the past few decades, the regulatory affairs profession has become more internationalized. This prompted the need for new competencies grounded in the transnational and cross-disciplinary contexts in which these professionals are required to operate.
Methodology: A convenience sample of experienced regulatory affairs professionals from multiple disciplines contributed to the development of transnational competencies for a master’s program in regulatory affairs using a transdisciplinary framework.
Contribution: An applied exemplar in which to understand how transdisciplinary characteristics can be communicated and applied in higher education.
Recommendations for Practitioners: This paper recommends how competencies developed from a regulatory affairs program can serve as exemplars for other applied transdisciplinary higher education programs.
Impact on Society: This framework provides a seldom-used reflective approach to regulatory affairs education that utilizes cross-disciplinary theory to inform competence-based formation of professionals.
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