title: Advancing a Vision for Regulatory Science Training.
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.
authors.affiliation: Clinical & Translational Science Institute, University of Rochester Medical Center, Rochester, New York, USA.
authors.forename: Joan E
authors.initials: JE
authors.lastname: Adamo
authors.affiliation: Program for Regulatory Science & Medicine, Georgetown University, Washington, DC, USA.
authors.forename: Erin E
authors.initials: EE
authors.lastname: Wilhelm
authors.affiliation: Department of Public Health Sciences, University of Rochester Medical Center, Rochester, New York, USA.
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Steele
mesh_terms: D035843:Biomedical Research / Q000193:education* / Q000592:standards; D032921:Consensus; D003479:Curriculum; D018795:Device Approval / Q000592:standards; D017277:Drug Approval; D004517:Education, Professional / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D011361:Professional Competence; D016730:Program Development; D015397:Program Evaluation; D012108:Research Personnel / Q000193:education* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
keywords: competencies; regulatory science; training; translational science