Advancing a Vision for Regulatory Science Training

Joan E Adamo; Erin E Wilhelm; Scott J Steele

doi:10.1111/cts.12298

Advancing a Vision for Regulatory Science Training

Clin Transl Sci. 2015 Oct;8(5):615-8. doi: 10.1111/cts.12298. Epub 2015 Jun 17.

Authors

Joan E Adamo¹, Erin E Wilhelm², Scott J Steele³

Affiliations

¹ Clinical & Translational Science Institute, University of Rochester Medical Center, Rochester, New York, USA.
² Program for Regulatory Science & Medicine, Georgetown University, Washington, DC, USA.
³ Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York, USA.

Abstract

Regulatory science, a complex field which draws on science, law, and policy, is a growing discipline in medical-related applications. Competencies help define both a discipline and the criteria to measure high-quality learning experiences. This paper identifies competencies for regulatory science, how they were developed, and broader recommendations to enhance education and training in this burgeoning field, including a multifaceted training approach.

Keywords: competencies; regulatory science; training; translational science.

Publication types

Consensus Development Conference
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Biomedical Research / education*
Biomedical Research / standards
Consensus
Curriculum
Device Approval* / standards
Drug Approval*
Education, Professional / methods*
Education, Professional / standards
Guidelines as Topic
Humans
Professional Competence
Program Development
Program Evaluation
Research Personnel / education*
Research Personnel / standards
United States
United States Food and Drug Administration* / standards

Abstract

Publication types

MeSH terms

Grants and funding