REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

监管事务咨询支持服务

• 批准号: 10421162
• 负责人: CAROLINE SIGMAN
• 金额: $ 2.89万
• 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: 2021-06-04 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10421162
• 关键词: Area; Clinical; Consult; Contractor; Ensure; Guidelines; Label; Leadership; Methods; Preparation; Protocols documentation; Regulation; Regulatory Affairs; Reporting; Risk; Role; Services; Time; TimeLine; United States Food and Drug Administration; United States National Institutes of Health; Work; pre-clinical; programs

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network 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.

承包商应为NIH蓝图神经疗法网络提供咨询支持服务：如下： 监管事务 监管事务顾问将提供领导，以支持临床前和临床的监管事务策略。可以要求顾问提供有关辅助研究和计划的指导，以确保团队符合IND应用程序的指南和时间表。顾问将与NIH员工，PIS，监管机构担任主要监管联系，并可能是食品药品监督管理局（FDA）的主要监管代表。 监管事务顾问的作用可能包括但不限于以下职责： •在项目团队中工作以制定监管策略，确定监管风险并及时批准。 •就与监管策略有关的问题建议NIH的员工和项目团队；确定有关制定法规的关注领域。 •提供和审查规格，方法，SOP，协议，报告，标签等的输入，以进行监管合规性。 •开发和管理监管提交的时间表。 •独立工作以完全分配的项目。 •有效地协调CRO和其他顾问的活动，以根据需要准备监管提交。