Communicating Transdisciplinary Characteristics In Global Regulatory Affairs: An Example From Health Professions Education

Daniela Drago, Paige McDonald, Gaetano R Lotrecchiano
Informing Science: The International Journal of an Emerging Transdiscipline  •  Volume 21  •  2018  •  pp. 219-234

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.

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.

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.

An applied exemplar in which to understand how transdisciplinary characteristics can be communicated and applied in higher education.

This paper recommends how competencies developed from a regulatory affairs program can serve as exemplars for other applied transdisciplinary higher education programs.

This framework provides a seldom-used reflective approach to regulatory affairs education that utilizes cross-disciplinary theory to inform competence-based formation of professionals.

transdisciplinary, competencies, regulatory affairs, higher education
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