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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
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| 자료유형 | 단행본 |
|---|---|
| 서명/저자사항 | 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, National Academies of Sciences, Engineering, and Medicine. |
| 개인저자 | Boname, Morgan L.,author. Gee, Amanda Wagner,author, Claiborne, Anne B.,author, |
| 단체저자명 | National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation,issuing body. |
| 발행사항 | Washington, DC: National Academies Press, [2016]. |
| 형태사항 | 1 online resource (1 PDF file (xvi, 87 pages)): illustrations. |
| 기타형태 저록 | Print version: Advancing the discipline of regulatory science for medical product development. Washington, DC : the National Academies Press, [2016] 0309438845 |
| ISBN | 9780309438841 0309438845 9780309438858 0309438853 |
| 서지주기 | Includes bibliographical references. |
| 내용주기 | 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. |
| 요약 | 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. |
| 기금정보주기 | This activity was supported by AbbVie, Inc.; the American Diabetes Association; American Society of Microbiology; Amgen Inc. (Contract No. GHCCOPS-CSARF-63987); Association of American Medical Colleges; AstraZeneca; Baxter BioScience; Burroughs Wellcome Fund (Contract No. 1015149); Critical Path Institute; Doris Duke Charitable Foundation (Contract No. 2015103); Eli Lilly & Co.; FasterCures; Friends of Cancer Research; GlaxoSmithKline (Contract No. 005319); Johnson & Johnson; Merck & Co., Inc. (Contract No. CMO-141224-000649); National Institutes of Health (NIH) (Contract No. HHSN263201200074I; Task Order HHSN26300023): National Cancer Institute (NIH), National Center for Advancing Translational Sciences (NIH), National Institute of Allergy and Infectious Diseases (NIH), National Institute of Mental Health (NIH), and National Institute of Neurological Disorders and Stroke (NIH); New England Journal of Medicine; Pfizer Inc.; Sanofi; Takeda Pharmaceuticals (Contract No. 53108); and U.S. Food and Drug Administration (Contract No. 1R13FD005496-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| 회의명 | Advancing the Discipline of Regulatory Science for Medical Product Development: an Update on Progress and a Forward-Looking Agenda (Workshop) (2015 : Washington, D.C.) |
| 주제명(단체명) | United States. --Food and Drug Administration. |
| 주제명(지명) | United States |
| 일반주제명 | Drug Discovery Government Regulation Drug and Narcotic Control Consumer Product Safety Equipment and Supplies Therapies, Investigational Drug development --Technological innovations --United States. Research. Pharmaceutical policy --United States. MEDICAL / Pharmacology |
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