REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
批准号:
10788190
负责人:
CAROLINE SIGMAN
金额:
$2.14万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-09-14 至 2023-09-13
关键词:
AreaClinicalContractorDevelopmentGuidelinesHelping to End Addiction Long-termLabelLeadershipMethodsOpiate AddictionOpioidPainPain managementPreparationProgram DevelopmentProtocols documentationPublic HealthRegulationRegulatory AffairsReportingResearchRiskRoleServicesSpecific qualifier valueSpeedUnited States Food and Drug AdministrationUnited States National Institutes of HealthWorkclinical painimprovednovelopioid misusepre-clinicalprogramstimeline
中文摘要
承包商应提供咨询支持服务,以帮助结束成瘾长期(HEAL)项目如下:
法规事务
法规事务顾问将领导支持临床前和临床的法规事务策略。顾问可能会被要求提供IND启动研究和项目的指导,以确保团队符合IND申请的指南和时间表。顾问将作为NIH工作人员、PI、监管机构的主要监管联系人,也可能是美国食品药品监督管理局(FDA)的主要监管代表。
法规事务顾问的职责可能包括但不限于以下职责和任务:
· 与项目团队合作,制定监管策略,识别监管风险,并及时获得批准。
· 就监管策略相关问题向NIH工作人员和项目团队提供建议;确定有关制定法规的关注领域。
· 为规范、方法、SOP、方案、报告、标签等提供输入和审查,以确保法规合规性。
· 制定和管理监管提交的时间表。
· 独立完成指定项目。
· 有效协调CRO和其他顾问的活动,以准备必要的监管申报资料。
疼痛;疼痛治疗发展计划;疼痛
英文摘要
The Contractor shall provide consulting support services to Helping End Addiction Long-term (HEAL) projects as follows:
Regulatory Affairs
Regulatory Affairs consultants will provide leadership in support of regulatory affairs strategies for preclinical and clinical. Consultants may be asked to provide guidance on IND-enabling studies and programs to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, regulatory agencies, and may also be the primary regulatory representative to the Food and Drug Administration (FDA).
The role of the Regulatory Affairs consultant may include but is not limited to the following responsibilities and tasks:
• Work within project teams to develop regulatory strategies, identify regulatory risks, and enable timely approval.
• Advise NIH staff and project teams on issues related to regulatory strategy; identify areas of concern regarding developing regulations.
• Provide input on and review specifications, methods, SOPs, protocols, reports, labeling, etc. for regulatory compliance.
• Develop and manage timelines for regulatory submissions.
• Work independently to complete assigned projects.
• Work effectively to coordinate the activities of CROs and other consultants in the preparation of regulatory submissions as necessary.
Pain; Pain Therapy Development Program; Pain
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
THE PURPOSE OF THIS REQUIREMENT IS TO PROVIDE REGULATORY SERVICES AND TECHNICAL SUPPORT TO THE DIVISION OF CANCER PREVENTION (DCP) AT THE NATIONAL CANCER INSTITUTE (NCI). NCI AND DCP HAVE A RECURRING
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批准号:10974513
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项目类别:
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资助金额:$297.5万
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财政年份:2023
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负责人:CAROLINE SIGMAN
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依托单位:
PROVIDE A VARIETY OF CRITICAL CANCER PREVENTION INFORMATION MANAGEMENT FUNCTIONS
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批准号:10974491
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项目类别:
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资助金额:$240.35万
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财政年份:2023
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
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批准号:10788189
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项目类别:
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资助金额:$1.61万
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财政年份:2022
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负责人:CAROLINE SIGMAN
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依托单位:
Technical Information Research Resources for Cancer Preventive Agent Development
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批准号:10447554
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项目类别:
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资助金额:$236.19万
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财政年份:2021
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负责人:CAROLINE SIGMAN
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依托单位:
MEDICAL WRITING CONSULTING AND DRUG DOSSIER DEVELOPMENT SUPPORT SERVICES
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批准号:10428343
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项目类别:
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资助金额:$8.21万
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财政年份:2021
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
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批准号:10551057
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项目类别:
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资助金额:$6.27万
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财政年份:2021
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
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批准号:10421162
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项目类别:
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资助金额:$2.89万
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财政年份:2021
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
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批准号:10718893
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项目类别:
-
资助金额:$1.07万
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财政年份:2021
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负责人:CAROLINE SIGMAN
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依托单位:
MEDICAL WRITING CONSULTING AND DRUG DOSSIER DEVELOPMENT SUPPORT SERVICES
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批准号:10703336
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项目类别:
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资助金额:$1.41万
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财政年份:2020
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负责人:CAROLINE SIGMAN
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依托单位:
MEDICAL WRITING CONSULTING AND DRUG DOSSIER DEVELOPMENT SUPPORT SERVICES
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批准号:10285593
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项目类别:
-
资助金额:$4.04万
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财政年份:2020
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES
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批准号:10285594
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项目类别:
-
资助金额:$0.5万
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财政年份:2020
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负责人:CAROLINE SIGMAN
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依托单位:
Technical Information Research Resources for Cancer Preventive Agent Development
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批准号:10219787
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项目类别:
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资助金额:$231.58万
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财政年份:2020
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负责人:CAROLINE SIGMAN
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依托单位:
MEDICAL WRITING CONSULTING AND DRUG DOSSIER DEVELOPMENT SUPPORT SERVICES
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批准号:10807950
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项目类别:
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资助金额:$2.86万
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财政年份:2020
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负责人:CAROLINE SIGMAN
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依托单位:
Technical Information Research Resources for Cancer Preventive Agent Development
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批准号:10018593
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项目类别:
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资助金额:$227.08万
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财政年份:2019
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负责人:CAROLINE SIGMAN
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依托单位:
Technical Information Research Resources for Cancer Preventive Agent Development
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批准号:10683696
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项目类别:
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资助金额:$234.56万
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财政年份:2018
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负责人:CAROLINE SIGMAN
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依托单位:
PURPOSE: TO OBLIGATE FUNDS TO FULLY FUND PERFORMANCE UNDER TASK ORDER NO. 04 AND UPDATE SECTIONS B AND G OF THE CONTRACT.CONTRACT AMOUNT: NOT TO EXC
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批准号:10286488
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项目类别:
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资助金额:$8.31万
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财政年份:2017
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负责人:CAROLINE SIGMAN
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依托单位:
REGULATORY AFFAIRS SUPPORT. SEPTEMBER 22, 2017 - SEPTEMBER 21, 2022. N01DA-17-8933.
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批准号:10044125
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项目类别:
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资助金额:$4.7万
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财政年份:2017
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负责人:CAROLINE SIGMAN
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依托单位:
TECHNICAL INFORMATION RESEARCH RESOURCES FOR CANCER PREVENTIVE AGENT DEVELOPMENT
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批准号:7542153
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项目类别:
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资助金额:$247.88万
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财政年份:2004
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负责人:CAROLINE SIGMAN
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依托单位:--
REGULATORY SUPPORT FOR CANCER PREVENTION AGENT DEVELOPMENT
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批准号:7542156
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项目类别:
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资助金额:$118.46万
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财政年份:2004
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负责人:CAROLINE SIGMAN
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依托单位:--
MULTIDISCIPLINED ANALYSIS OF CHEMOPREVENTIVE AGENTS
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批准号:3621869
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项目类别:
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资助金额:$16.75万
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财政年份:1987
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负责人:CAROLINE SIGMAN
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依托单位:
国内基金
海外基金
Molecular Interaction Reconstruction of Rheumatoid Arthritis Therapies Using Clinical Data
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批准号:31070748
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项目类别:面上项目
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资助金额:34.0万元
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批准年份:2010
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负责人:Christine Nardini
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依托单位: