Drago Daniela, Shire Sandra, Ekmekci Ozgur
1 Department of Clinical Research and Leadership, School of Medicine and Health Sciences, The George Washington University, Washington, DC, USA.
2 Arizona State University, Phoenix, AZ, USA.
Ther Innov Regul Sci. 2016 May;50(3):330-336. doi: 10.1177/2168479015620440.
The growing belief that an effective regulatory function is vital to the successful development of medical products has spurred initiatives in regulatory education. To help prepare highly skilled professionals, some academic institutions have begun to incorporate new competencies into their curricula and to offer innovative programs in the field of regulatory studies.
This study is the first national survey aimed at identifying the degree of adoption of an educational model based on well-defined professional competencies for graduate programs in regulatory studies.
Respondents disclosed the challenges faced by faculty in implementing such a model. The study revealed the relevancy of this type of model and that a competency-based approach is largely perceived as a prerequisite for aligning a program's mission and vision with the skills that graduates need in the job market. Survey results show a strong general agreement regarding the suitability of a competency-based education model for regulatory studies.
The challenges in implementing such a model, as described by survey participants, are significant but can be addressed. The barriers to implementation of regulatory curricula based on a competency-based education model should be better understood so that academic programs can educate highly skilled regulatory professionals. Such a workforce could best contribute to the delivery of high-quality, safe, and effective medical products.
人们越来越相信有效的监管职能对医疗产品的成功研发至关重要，这推动了监管教育方面的举措。为帮助培养高技能专业人才，一些学术机构已开始将新的能力要求纳入其课程，并在监管研究领域提供创新项目。
本研究是首次全国性调查，旨在确定监管研究研究生项目采用基于明确专业能力的教育模式的程度。
受访者披露了教师在实施这种模式时面临的挑战。该研究揭示了这种模式的相关性，并且基于能力的方法在很大程度上被视为使项目的使命和愿景与毕业生在就业市场所需技能相匹配的先决条件。调查结果表明，对于基于能力的教育模式适用于监管研究，普遍达成了强烈共识。
正如调查参与者所描述的，实施这种模式面临的挑战很大，但可以解决。应更好地理解基于能力的教育模式在实施监管课程方面的障碍，以便学术项目能够培养出高技能的监管专业人才。这样的人才队伍能够为提供高质量、安全和有效的医疗产品做出最大贡献。
