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Advancing the Discipline of Regulatory Science for Medical Product Development : An Update on Progress and a Forward-Looking Agenda: Workshop Summary

By: (Author) Board on Health Sciences Policy , (Author) and Translation Forum on Drug Discovery Development , (Author) and Medicine National Academies of Sciences Engineering , (Author) Health and Medicine Division , (Edited by) Amanda Wagner Gee , (Edited by) Anne B. Claiborne , (Edited by) Morgan L. Boname

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Ksh 7,200.00

Format: Paperback or Softback

ISBN-10: 0309438845

ISBN-13: 9780309438841

Publisher: National Academies Press

Imprint: National Academies Press

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Aug 11th, 2016

Print length: 104 Pages

Product Classification: Medicine

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The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop. Table of ContentsFront Matter1 Introduction2 Characterizing the Regulatory Science Landscape3 Regulatory Science Applications: Using Case Studies to Focus on Approaches to Advance the Discipline4 Regulatory Science Infrastructure and Workforce5 Challenges and Opportunities in Regulatory ScienceAppendix A: BibliographyAppendix B: Workshop AgendaAppendix C: Participant Biographies

The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.

In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

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