Article(id=1322627820031947512, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1591718400000, acceptedDateStr=2020-06-10, onlineDate=1793268645532, onlineDateStr=2026-10-29, pubDate=1615737600000, pubDateStr=2021-03-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268645532, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268645532, creator=13701087609, updateTime=1793268645532, updator=13701087609, issue=Issue{id=1322627786464936095, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='5', pageStart='385', pageEnd='480', issueExtLink='null', onlineDate='null', pubDate='1615737600000', pubDateStr='2021-03-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268637529, creator='13701087609', updateTime=1793269201588, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322630152530539005, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322630152530539006, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627786464936095, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=385, endPage=393, ext={EN=ArticleExt(id=1322627820187136761, articleId=1322627820031947512, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The cultivation practice of drug regulatory science talents in the United States under the background of regulatory science and its enlightenment to China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The research and construction of drug regulatory science has become the focus of drug supervision strategies in the world in this century, and the construction of talent teams is one of the first considerations in the research and construction of regulatory science. China is still in its infancy in the cultivation of regulatory science talents, and there are prominent problems such as the small scale, shallow degree, and chaotic system of talent cultivation. The United States has been exploring the cultivation of talents for drug regulatory science for many years, and has formed a mature regulatory science talent training system. This article studies the innovative practice of the training of regulatory science talents in the United States, analyzes and summarizes its talent training orientation and specific training measures to understand the deficiencies in China, and on the basis of which, suggestions were put forward to improve the cultivation system of drug regulatory science talents in China.

, authors=Liang HE1, Chen-dong DONG2, Ning-ying MAO1, Jun LI1, authorsList=Liang HE, Chen-dong DONG, Ning-ying MAO, Jun LI, authorCompany=null, correspAuthors=Jun LI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322627820413629178, articleId=1322627820031947512, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=美国药品监管科学人才培养实践探究及对我国的启示, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

药品监管科学研究与建设已成为世界各国21世纪药品监管战略重点,而人才队伍建设是进行监管科学研究与建设首要考虑的问题之一。我国对于监管科学人才培养尚处于起步阶段,存在人才培养规模小、程度浅、体系乱等突出问题。美国在药品监管科学人才培养方面探索多年,已形成较为成熟的监管科学人才培养体系。本文通过对美国药品监管科学人才培养创新实践进行研究,对其人才培养定位以及具体培养措施进行分析总结,以了解我国在药品监管科学人才培养方面存在的不足,并在此基础上提出完善我国药品监管科学人才培养体系的建议。

, authors=贺亮1, 董晨东2, 茅宁莹1, 李军1, authorsList=贺亮, 董晨东, 茅宁莹, 李军, authorCompany=null, correspAuthors=李军, authorNote=

董晨东,男,硕士,研究方向为OTC药品政策研究。

贺亮,男,硕士研究生,研究方向为国家药物政策。E-mail:。

, correspAuthorsNote=
李军,女,讲师,主要研究方向为医药产业技术创新政策与管理。联系电话:(025)86185038,E-mail:。
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贺亮,男,硕士研究生,研究方向为国家药物政策。E-mail:。

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贺亮,男,硕士研究生,研究方向为国家药物政策。E-mail:。

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tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=EMA. Road map to 2015-The European Medicines Agency's contribution to science, medicines and health[EB/OL]. [2010-12-16]. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf., articleTitle=null, refAbstract=null), Reference(id=1322627824188502816, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=URMC. Regulatory Science Competencies in 11 Core Thematic Areas[EB/OL]. [2016-04-26]. https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/office-research-alliances/documents/cts12298-sup-0002-AppendixS2.pdf., articleTitle=null, refAbstract=null), Reference(id=1322627824251417377, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=Australian Government Department of Health. Assessment of Australia's regulatory science workforce needs-final report[EB/OL]. [2017-06]. https://www1.health.gov.au/internet/main/publishing.nsf/Content/A12B57E41EC9F326CA257BF0001F9E7D/$File/Aust-Regulatory-Science-Workforce-Needs-July2017.pdf., articleTitle=null, refAbstract=null), Reference(id=1322627824318526242, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Strategic Plan for Regulatory Science[EB/OL]. [2018-03-29]. https://www.fda.gov/science-research/advancing-regulatory-science/strategic-plan-regulatory-science., articleTitle=null, refAbstract=null), Reference(id=1322627824373052195, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. The Commissioner's Fellowship Program-Outcomes Evaluation Report[EB/OL]. [2017-12-06]. https://www.fda.gov/media/105686/download., articleTitle=null, refAbstract=null), Reference(id=1322627824431772452, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Regulatory Science Extramural Research and Development Projects[EB/OL]. [2018-03-29]. https://www.fda.gov/science-research/advancing-regulatory-science/regulatory-science-extramural-research-and-development-projects., articleTitle=null, refAbstract=null), Reference(id=1322627824507269925, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Organs-On-Chips for Radiation Countermeasures[EB/OL]. [2019-12-16]. https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/organs-chips-radiation-countermeasures., articleTitle=null, refAbstract=null), Reference(id=1322627824570184486, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Mining Social Media for Adverse Event Surveillance[EB/OL]. [2016-11-17]. https://wayback.archive-it.org/7993/20180126133601/https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm455305.htm., articleTitle=null, refAbstract=null), Reference(id=1322627824628904743, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Centers of Excellence in Regulatory Science and Innovation (CERSIs)[EB/OL]. [2018-06-09]. https://www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis., articleTitle=null, refAbstract=null), Reference(id=1322627824687625000, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=CERSI-Johns Hopkins University. About Us[EB/OL]. [2019-12-21]. https://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/about-us/., articleTitle=null, refAbstract=null), Reference(id=1322627824746345257, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) Steering Committee Charter[EB/OL]. [2019-05-30]. https://www.fda.gov/media/123274/download., articleTitle=null, refAbstract=null), Reference(id=1322627824813454122, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=University of Southern California. Regulatory Science[EB/OL]. [2019-12-28]. https://regulatory.usc.edu/., articleTitle=null, refAbstract=null), Reference(id=1322627824880562987, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627820031947512, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=University of Maryland. 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美国药品监管科学人才培养实践探究及对我国的启示
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贺亮 1 , 董晨东 2 , 茅宁莹 1 , 李军 1
中国新药杂志 | 新药述评与论坛 2021,30(5): 385-393
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中国新药杂志 |新药述评与论坛 2021 , 30 (5) : 385 -393
美国药品监管科学人才培养实践探究及对我国的启示
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贺亮1 , 董晨东2, 茅宁莹1, 李军1
作者信息
  • 1中国药科大学国际医药商学院,南京 211198
  • 2华润三九医药股份有限公司,深圳 518110
通讯作者:
李军,女,讲师,主要研究方向为医药产业技术创新政策与管理。联系电话:(025)86185038,E-mail:。
作者简介:

董晨东,男,硕士,研究方向为OTC药品政策研究。

贺亮,男,硕士研究生,研究方向为国家药物政策。E-mail:。

The cultivation practice of drug regulatory science talents in the United States under the background of regulatory science and its enlightenment to China
Liang HE1 , Chen-dong DONG2, Ning-ying MAO1, Jun LI1
Affiliations
  • 1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
  • 2China Resources Sanjiu Medical & Pharmaceutical Co., Ltd., Shenzhen 518110, China
出版时间: 2021-03-15
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药品监管科学研究与建设已成为世界各国21世纪药品监管战略重点,而人才队伍建设是进行监管科学研究与建设首要考虑的问题之一。我国对于监管科学人才培养尚处于起步阶段,存在人才培养规模小、程度浅、体系乱等突出问题。美国在药品监管科学人才培养方面探索多年,已形成较为成熟的监管科学人才培养体系。本文通过对美国药品监管科学人才培养创新实践进行研究,对其人才培养定位以及具体培养措施进行分析总结,以了解我国在药品监管科学人才培养方面存在的不足,并在此基础上提出完善我国药品监管科学人才培养体系的建议。

监管科学  /  人才培养  /  能力素质

The research and construction of drug regulatory science has become the focus of drug supervision strategies in the world in this century, and the construction of talent teams is one of the first considerations in the research and construction of regulatory science. China is still in its infancy in the cultivation of regulatory science talents, and there are prominent problems such as the small scale, shallow degree, and chaotic system of talent cultivation. The United States has been exploring the cultivation of talents for drug regulatory science for many years, and has formed a mature regulatory science talent training system. This article studies the innovative practice of the training of regulatory science talents in the United States, analyzes and summarizes its talent training orientation and specific training measures to understand the deficiencies in China, and on the basis of which, suggestions were put forward to improve the cultivation system of drug regulatory science talents in China.

regulatory science  /  talent training  /  competency
贺亮, 董晨东, 茅宁莹, 李军. 美国药品监管科学人才培养实践探究及对我国的启示. 中国新药杂志, 2021 , 30 (5) : 385 -393 .
Liang HE, Chen-dong DONG, Ning-ying MAO, Jun LI. The cultivation practice of drug regulatory science talents in the United States under the background of regulatory science and its enlightenment to China[J]. Chinese Journal of New Drugs, 2021 , 30 (5) : 385 -393 .
  • 中国药科大学“双一流”学科创新团队建设项目(CPU2018GY39)
  • 中国药品监督管理研究会资助课题:监管科学发展视角下的药品监管人才能力素质模型研究——基于长三角区域的调查研究(2018)
  • 监管科学视角下创新药审评决策自由裁量权研究(2019)
参考文献 引证文献
排序方式:
[1]
刘昌孝, 程翼宇, 范骁辉. 转化研究: 从监管科学到科学监管的药物监管科学的发展[J]. 药物评价研究, 2014, 3(5): 385-391.
[2]
EMA. Road map to 2015-The European Medicines Agency's contribution to science, medicines and health[EB/OL]. [2010-12-16]. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf.
[3]
URMC. Regulatory Science Competencies in 11 Core Thematic Areas[EB/OL]. [2016-04-26]. https://www.urmc.rochester.edu/MediaLibraries/URMCMedia/office-research-alliances/documents/cts12298-sup-0002-AppendixS2.pdf.
[4]
Australian Government Department of Health. Assessment of Australia's regulatory science workforce needs-final report[EB/OL]. [2017-06]. https://www1.health.gov.au/internet/main/publishing.nsf/Content/A12B57E41EC9F326CA257BF0001F9E7D/$File/Aust-Regulatory-Science-Workforce-Needs-July2017.pdf.
[5]
FDA. Strategic Plan for Regulatory Science[EB/OL]. [2018-03-29]. https://www.fda.gov/science-research/advancing-regulatory-science/strategic-plan-regulatory-science.
[6]
FDA. The Commissioner's Fellowship Program-Outcomes Evaluation Report[EB/OL]. [2017-12-06]. https://www.fda.gov/media/105686/download.
[7]
FDA. Regulatory Science Extramural Research and Development Projects[EB/OL]. [2018-03-29]. https://www.fda.gov/science-research/advancing-regulatory-science/regulatory-science-extramural-research-and-development-projects.
[8]
FDA. Organs-On-Chips for Radiation Countermeasures[EB/OL]. [2019-12-16]. https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/organs-chips-radiation-countermeasures.
[9]
FDA. Mining Social Media for Adverse Event Surveillance[EB/OL]. [2016-11-17]. https://wayback.archive-it.org/7993/20180126133601/https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm455305.htm.
[10]
FDA. Centers of Excellence in Regulatory Science and Innovation (CERSIs)[EB/OL]. [2018-06-09]. https://www.fda.gov/science-research/advancing-regulatory-science/centers-excellence-regulatory-science-and-innovation-cersis.
[11]
CERSI-Johns Hopkins University. About Us[EB/OL]. [2019-12-21]. https://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/about-us/.
[12]
FDA. FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) Steering Committee Charter[EB/OL]. [2019-05-30]. https://www.fda.gov/media/123274/download.
[13]
University of Southern California. Regulatory Science[EB/OL]. [2019-12-28]. https://regulatory.usc.edu/.
[14]
University of Maryland. Master of Science and Graduate Certificate in Regulatory Science[EB/OL]. [2019-12-28]. https://www.pharmacy.umaryland.edu/academics/regulatoryscience/.
[15]
University of Georgia. Regulatory Sciences Masters Program[EB/OL]. [2019-12-28]. http://www.rs.rx.uga.edu/program_info/reg_affairs_masters/.
[16]
刘昌孝. 国际药品监管科学发展概况[J]. 药物评价研究, 2017, 40(8): 1029-1043.
[17]
北京大学临床研究所. 北京大学临床研究所简介[EB/OL]. [2019-12-28]. http://pucri.bjmu.edu.cn/cn/basic-19-20.html.
[18]
复旦大学药学院. “中丹药事监管科学中心”联席会议在复旦药学院召开[EB/OL]. [2016-12-09]. http://spfdu.fudan.edu.cn/NewsInfo_list.aspx?BID=66&ShowID=1975&SID=68.
[19]
清华大学医学院. 医学院医药监管科学研究中心[EB/OL]. [2019-04-09]. http://www.med.tsinghua.edu.cn/SingleServlet?newsId=1520.
[20]
刘清峰, 刘洋, 蒋海洪, 等. 基于监管科学的医疗器械监管人才培养探索设计[J]. 中国药事, 2018, 32(11): 1500-1504.
[21]
NMPA. 国家药监局启动中国药品监管科学行动计划[EB/OL]. [2019-04-30]. http://www.nmpa.gov.cn/WS04/CL2056/337150.html.
[22]
FDA. Section 1. Modernize Toxicology to Enhance Product Safety: Strategic Plan for Regulatory Science[EB/OL]. [2018-03-29]. https://www.fda.gov/science-research/advancing-regulatory-science/section-1-modernize-toxicology-enhance-product-safety-strategic-plan-regulatory-science.
2021年第30卷第5期
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  • 首发时间:2026-10-29
  • 出版时间:2021-03-15
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  • 录用日期:2020-06-10
基金
中国药科大学“双一流”学科创新团队建设项目(CPU2018GY39)
中国药品监督管理研究会资助课题:监管科学发展视角下的药品监管人才能力素质模型研究——基于长三角区域的调查研究(2018)
监管科学视角下创新药审评决策自由裁量权研究(2019)
作者信息
    1中国药科大学国际医药商学院,南京 211198
    2华润三九医药股份有限公司,深圳 518110

通讯作者:

李军,女,讲师,主要研究方向为医药产业技术创新政策与管理。联系电话:(025)86185038,E-mail:。
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
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