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
承包商应为帮助戒瘾长期(Hear)项目提供咨询支持服务,具体如下:
监管事务
监管事务顾问将在支持临床前和临床监管事务战略方面发挥领导作用。可能会要求顾问就支持IND的研究和计划提供指导,以确保团队满足IND申请的指导方针和时间表。顾问将作为NIH工作人员、PI、监管机构的主要监管联系人,也可能是食品和药物管理局(FDA)的主要监管代表。
监管事务顾问的作用可包括但不限于以下职责和任务:
·在项目团队内合作,制定监管战略,识别监管风险,并及时获得批准。
·就与监管战略相关的问题向NIH工作人员和项目团队提供建议;确定与制定监管有关的关切领域。
·提供关于规范、方法、标准操作规程、协议、报告、标签等的信息,并对其进行审查,以确保合规性。
·制定和管理监管提交的时间表。
·独立完成分配的项目。
·在必要时有效协调CRO和其他顾问在准备监管呈件方面的活动。
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:
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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:
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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: