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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 (Paperback)
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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 (Paperback)
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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 Contents Front Matter 1
Introduction 2 Characterizing the Regulatory Science Landscape 3
Regulatory Science Applications: Using Case Studies to Focus on
Approaches to Advance the Discipline 4 Regulatory Science
Infrastructure and Workforce 5 Challenges and Opportunities in
Regulatory Science Appendix A: Bibliography Appendix B: Workshop
Agenda Appendix C: Participant Biographies
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