REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

监管事务咨询支持服务

• 批准号: 10718893
• 负责人: CAROLINE SIGMAN
• 金额: $ 1.07万
• 依托单位: CCS ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-21 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718893
• 关键词: Area; Clinical; Consult; Contractor; Ensure; Guidelines; Helping to End Addiction Long-term; Label; Leadership; Methods; Opiate Addiction; Opioid; Pain; Pain management; Preparation; Protocols documentation; Public Health; Regulation; Regulatory Affairs; Reporting; Research; Risk; Role; Services; Speed; Time; TimeLine; United States Food and Drug Administration; United States National Institutes of Health; Work; clinical pain; improved; opioid misuse; pre-clinical; programs

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.

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。