Core D: PREVENT Program Regulatory Affairs Core

核心D的目的是提供监管和技术基础设施 维护和管理一致的法规遵从性的专业知识 预防计划中所有项目的要求。核心包括两个独立的 但相辅相成的组成部分：(1)监督所需的临床前工作 成功的IND，包括与FDA的互动和(Ii)管理和监督 1期前临床试验的法规遵从性、培训和实施。这个 CORE将管理、跟踪、开发并为所有监管部门提供协调一致的响应 提交和机构互动。这将包括从GMP之前的过渡到 环丙沙星原料药和制剂制造、中试和GLP临床前研究 毒理学、与外部监管机构的战略互动以及IND 制定和提交文件，重点放在监管培训和教育以及 标准化该计划的监管做法的目标。核心还将提供 制定全面质量管理计划，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督活动，并将作为中心 文档控制存储库。

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.