regulatory affairs

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

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.




regulatory affairs

Carl Denny Celebrated for Dedication to the Field of Regulatory Affairs

Carl Denny channels years of expertise into his work with Abeona Therapeutics




regulatory affairs

Medicines for Europe 23rd Regulatory Affairs Conference 2025

<p> <b>23rd Regulatory Affairs Conference 202</b><b>5</b><br /> <b>27</b><b>‒</b><b>28 February 2025</b><br /> Hilton Amsterdam Airport Schiphol<br />Amsterdam, The Netherlands</p>




regulatory affairs

Testimony by Deputy Attorney General James M. Cole Before the Subcommittee on Economic Growth, Job Creation and Regulatory Affairs Committee on Oversight and Government Reform

We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter