Improving Regulatory Education: Can We Reconcile Employers' Expectations With Academic Offerings?. (May 2016)

• Record Type: Journal Article
• Authors: Drago, Daniela; Shire, Sandra; Ekmekci, Ozgur
• Is Part Of: Therapeutic innovation & regulatory science. Volume 50:Number 3(2016:May)
• Page Start: 330
• Page End: 336
• Publication Date: 2016-05
• Subjects: regulatory science -- regulatory affairs -- competencies -- competency-based education; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479015620440
• Languages: English
• ISSNs: 2168-4790

Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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.