Coverart for item
The Resource Advancing the Discipline of Regulatory Science for Medical Product Development : an Update on Progress and a Forward-Looking Agenda : workshop summary, Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine, (electronic resource)

Advancing the Discipline of Regulatory Science for Medical Product Development : an Update on Progress and a Forward-Looking Agenda : workshop summary, Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine, (electronic resource)

Label
Advancing the Discipline of Regulatory Science for Medical Product Development : an Update on Progress and a Forward-Looking Agenda : workshop summary
Title
Advancing the Discipline of Regulatory Science for Medical Product Development
Title remainder
an Update on Progress and a Forward-Looking Agenda : workshop summary
Statement of responsibility
Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine
Title variation
Discipline of Regulatory Science for Medical Product Development
Creator
Contributor
Subject
Genre
Language
eng
Summary
"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"--Publisher's description
Cataloging source
YDXCP
http://library.link/vocab/creatorName
Boname, Morgan L
Dewey number
615.1/9
LC call number
RM301.25
LC item number
.B65 2016
NLM call number
QV 745
http://library.link/vocab/relatedWorkOrContributorDate
2015
http://library.link/vocab/relatedWorkOrContributorName
  • Gee, Amanda Wagner
  • Claiborne, Anne B
  • National Academies of Sciences, Engineering, and Medicine (U.S.)
  • Advancing the Discipline of Regulatory Science for Medical Product Development: an Update on Progress and a Forward-Looking Agenda (Workshop)
http://library.link/vocab/subjectName
  • United States
  • Drug development
  • Research
  • Pharmaceutical policy
  • Drug Discovery
  • United States
  • United States
Label
Advancing the Discipline of Regulatory Science for Medical Product Development : an Update on Progress and a Forward-Looking Agenda : workshop summary, Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references (pages 47-48)
Contents
Introduction -- Characterizing the Implementation science landscape -- Regulatory science applications: using case studies to focus on approaches to advance the discipline -- Regulatory science infrastructure and workforce -- Challenges and opportunities in regulatory science -- Appendix A: Bibliography -- Appendix B: Workshop agenda -- Appendix C: Participant biographies
Control code
OCM1bookssj0001738360
Dimensions
unknown
Isbn
9780309438841
Lccn
2016499761
Specific material designation
remote
System control number
(WaSeSS)bookssj0001738360
Label
Advancing the Discipline of Regulatory Science for Medical Product Development : an Update on Progress and a Forward-Looking Agenda : workshop summary, Morgan L. Boname, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, The National Academies of Sciences, Engineering, Medicine, (electronic resource)
Publication
Bibliography note
Includes bibliographical references (pages 47-48)
Contents
Introduction -- Characterizing the Implementation science landscape -- Regulatory science applications: using case studies to focus on approaches to advance the discipline -- Regulatory science infrastructure and workforce -- Challenges and opportunities in regulatory science -- Appendix A: Bibliography -- Appendix B: Workshop agenda -- Appendix C: Participant biographies
Control code
OCM1bookssj0001738360
Dimensions
unknown
Isbn
9780309438841
Lccn
2016499761
Specific material designation
remote
System control number
(WaSeSS)bookssj0001738360

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