Literature DB >> 26083660

Advancing a Vision for Regulatory Science Training.

Joan E Adamo1, Erin E Wilhelm2, Scott J Steele3.   

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.
© 2015 Wiley Periodicals, Inc.

Keywords:  competencies; regulatory science; training; translational science

Mesh：

Year:  2015        PMID： 26083660      PMCID： PMC5351091          DOI： 10.1111/cts.12298

Source DB:  PubMed          Journal:  Clin Transl Sci        ISSN： 1752-8054            Impact factor:   4.689


  5 in total

1.  The path to personalized medicine.

Authors:  Margaret A Hamburg; Francis S Collins
Journal:  N Engl J Med       Date:  2010-06-15       Impact factor: 91.245

2.  Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Authors:  Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde
Journal:  J Biomed Inform       Date:  2008-09-30       Impact factor: 6.317

3.  Curricular considerations for pharmaceutical comparative effectiveness research.

Authors:  Michael D Murray
Journal:  Pharmacoepidemiol Drug Saf       Date:  2011-01-10       Impact factor: 2.890

4.  The role of academic medical centers in advancing regulatory science.

Authors:  R J Meyer
Journal:  Clin Pharmacol Ther       Date:  2014-05       Impact factor: 6.875

5.  Strengthening the career development of clinical translational scientist trainees: a consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees.

Authors:  Frederick J Meyers; Melissa D Begg; Michael Fleming; Carol Merchant
Journal:  Clin Transl Sci       Date:  2012-03-02       Impact factor: 4.689
  5 in total
  5 in total

1.  Danish Physicians' Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study.

Authors:  Mikkel Lindskov Sachs; Morten Colding-Jørgensen; Per Helboe; Sofia Kälvemark Sporrong; Sven Frøkjaer; Katarina Jelic; Susanne Kaae
Journal:  Pharmaceut Med       Date:  2019-04

2.  Implementing and Evaluating a Mentor Training to Improve Support for Early-Career Scholars in Tobacco Regulatory Science.

Authors:  Christy D Di Frances; Ellen Childs; Jessica L Fetterman; Andrea C Villanti; Cassandra A Stanton; Abigail R Russo; Glenn A Hirsch; Amy C Solis; Emelia J Benjamin
Journal:  Nicotine Tob Res       Date:  2020-05-26       Impact factor: 4.244

3.  Teaching principles of translational science to a broad scientific audience using a case study approach: A pilot course from the National Center for Advancing Translational Sciences.

Authors:  Jessica M Faupel-Badger; Amanda L Vogel; Shadab F Hussain; Christopher P Austin; Matthew D Hall; Elizabeth Ness; Philip Sanderson; Pramod S Terse; Xin Xu; Krishna Balakrishnan; Samarjit Patnaik; Juan J Marugan; Udo Rudloff; Marc Ferrer
Journal:  J Clin Transl Sci       Date:  2022-03-21

4.  Translating innovation in biomedical research: Design and delivery of a competency-based regulatory science course.

Authors:  Alexandra J Greenberg-Worisek; Katherine E Cornelius; Luz Cumba Garcia; Felicity T Enders; Nilay D Shah; Anthony J Windebank
Journal:  J Clin Transl Sci       Date:  2019-12-23

5.  Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response.

Authors:  Sarah E Brewer; Elizabeth J Campagna; Elaine H Morrato
Journal:  J Clin Transl Sci       Date:  2019-09-13
  5 in total

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