Core D: PREVENT Program Regulatory Affairs Core

核心 D：预防计划监管事务核心

• 批准号: 8769377
• 负责人: IAN Michael MCGOWAN
• 金额: $ 15.37万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8769377
• 关键词: Blinded; Clinical; Clinical Data; Clinical Trials; Code; Confidentiality; Cyclic GMP; Data; Development; Drug Kinetics; Ensure; Gel; Goals; Housing; Human; Monitor; Peer Review; Pharmaceutical Preparations; Pharmacodynamics; Phase I Clinical Trials; Practice Management; Prevention; Process; Publications; Quality Control; Randomized; Regulation; Regulatory Affairs; Reporting; Research; Research Infrastructure; Sampling; Site; Systems Biology; Technical Expertise; Time; Toxicology; Training; Training and Education; Viral; Work; base; innovation; microbicide; pre-clinical; programs; quality assurance; rectal; rectal microbicide; repository; response; symposium; volunteer

The purpose of Core D is to provide an infrastructure of regulatory and technical expertise to maintain and manage consistent compliance with the regulatory requirements for all projects in the PREVENT Program. The Core includes two separate but complementary components: (i) oversight of the preclinical work required to support a successful IND, including interactions with the FDA and (ii) management and oversight of regulatory compliance, training, and implementation of a pre-Phase 1 clinical trial. The Core will manage, track, develop, and provide coordinated responses to all regulatory submissions and Agency interactions. This will include the transition from pre-GMP to cGMP drug substance and drug product manufacture, pilot and GLP preclinical toxicology, strategic interactions with external regulatory agencies, and IND development and submissions, with a focus on regulatory training and education and the goal of standardizing the Program's regulatory practices. The Core will also provide an overall Quality Management Plan, and implement and monitor quality control and quality assurance activities, as needed, throughout all program projects and cores. The Core will coordinate and direct all required self-monitoring activities and will serve as a central document control repository.

核心D的目的是提供监管和技术基础设施， 专业知识，以保持和管理一致的法规遵从性， 所有项目都在预防计划中。核心包括两个独立的 但补充组成部分：（一）监督所需的临床前工作， 成功的IND，包括与FDA的互动，以及（ii）管理和监督 监管合规性、培训和1期临床试验前的实施。的 核心将管理、跟踪、制定并提供对所有监管 提交和机构互动。这将包括从GMP前过渡到 cGMP原料药和制剂生产、中试和GLP临床前 毒理学、与外部监管机构的战略互动以及IND 开发和提交，重点是监管培训和教育， 标准化计划的监管实践的目标。核心还将提供一个 全面的质量管理计划，并实施和监督质量控制和质量 根据需要，在所有计划项目和核心中开展保证活动。核心 将协调和指导所有必要的自我监测活动，并将作为一个中心， 文件控制库。