Administrative Core

行政核心

• 批准号: 10665899
• 负责人: JOSHUA E MUSCAT
• 金额: $ 37.01万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665899
• 关键词: Adverse event; Advertising; Animal Experimentation; Authorization documentation; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Development; Doctor of Philosophy; Electronics; Ensure; Environment; Ethics; Faculty; Feedback; Funding; Funding Opportunities; Future; Goals; Government; Grant; Health; Health Sciences; Human Resources; Infrastructure; Institution; Laboratories; Laws; Leadership; Legal; Medicine; Mission; Monitor; Muscat; Parents; Peer Review; Pharmacology; Pilot Projects; Policies; Positioning Attribute; Printing; Procedures; Productivity; Psychiatry; Public Health; Quality Control; Recommendation; Reporting; Research; Research Personnel; Resource Allocation; Resources; Science; Scientist; Secure; Structure; Tobacco; Toxic effect; Training; Training Programs; United States National Institutes of Health; Universities; University of Texas M D Anderson Cancer Center; Work; addiction; authority; career; career development; college; data management; expectation; experience; good laboratory practice; human subject; meetings; member; next generation; operation; professor; recruit; response; success; symposium; timeline; tobacco control; tobacco products; tobacco regulatory science; webinar; working group

PROJECT SUMMARY / ABSTRACT: Administrative Core The goal of the Administrative Core is to promote an environment of communication and collaboration among Penn State TCORS investigators, across TCORS, and with CASEL and FDA and NIH staff. To accomplish this, the Core will work closely with our TCORS components to establish the governance procedures, prioritization, interaction, feedback and communication within the TCORS including its affiliate University of Texas MD Anderson Cancer Center. The Administrative Core will oversee the fiduciary, ethical and legal responsibilities of the TCORS and its members. The Core will manage and assume responsibility for responding to the prioritizations of the FDA, NIH and the TCORS funding opportunity announcement. This includes the conduct of scientific studies within the scientific domains of the RFA, forming an External Advisory Board (EAB) and arranging for annual meetings with NIH officials and the EAB. The Core will assume the responsibility for the Center’s rapid response capability, and adhering to recommendations and requests from the EAB, the Internal Advisory Board, CASEL, national TCORS working groups and initiatives. The Administrative Core will work to be at the forefront of FDA tobacco regulatory law, utilizing its EAB and Admin Core experts in regulatory law and tobacco regulatory science to guide our activities. The Core will encourage TCORS members to assume leadership positions in the national TCORS initiatives on working groups, webinars and other venues. The TCORS will be supported by the Penn State College of Medicine Center for Research on Tobacco and Health, which facilitates and coordinates tobacco research across the Departments and Graduate training programs in the College of Medicine The Steering Committee includes faculty members who have collaborated for many years on tobacco control and interdisciplinary tobacco research. The Steering Committee will meet at least weekly to insure that the Center adheres to state of-the-art science, its integrative theme, and make recommendations for changes in direction if necessary. The Core will insure that all activities, including career development, pilot projects, major projects, and collaboration with other TCORS are responsive to FDA regulatory needs and its authority. Based on the Penn State TCORS (2014-2019), which included many of the same PIs and Co-Is, we have had significant experience in the administration of a TCORS both locally and nationally. A key component of the Core is overseeing the Career Enhancement and Training Core. Our previous TCORS had over 20 trainees, many of which have received their own funding including NIH training grants, are now fully employed at the FDA Center for Tobacco Products, or have attained faculty positions at Penn State or elsewhere. The Career Enhancement Training Program is led by two former trainees, who are now faculty, and well positioned to continue the training and career development of the next generation of tobacco regulatory scientists.

项目总结/摘要：行政核心 行政核心的目标是促进沟通和协作的环境 在宾夕法尼亚州立大学TCORS研究人员中，在TCORS中，以及与CASEL和FDA和NIH工作人员。到 为了实现这一点，核心将与我们的TCORS组件密切合作，以建立治理 TCORS内部（包括其附属机构）的程序、优先级、互动、反馈和沟通 得克萨斯大学MD安德森癌症中心。行政核心将监督信托、道德和 以及TCORS及其成员的法律的责任。核心将管理并负责 响应FDA，NIH和TCORS资助机会公告的优先顺序。这 包括在RFA的科学领域内进行科学研究，形成外部咨询 董事会（EAB）和安排与NIH官员和EAB的年度会议。核心会假设 负责中心的快速反应能力，并遵守建议和要求， EAB、内部咨询委员会、CASEL、国家TCORS工作组和倡议。的 行政核心将致力于在FDA烟草监管法律的最前沿，利用其EAB和行政核心， 监管法律和烟草监管科学的核心专家指导我们的活动。核心将鼓励 TCORS成员在TCORS国家工作组倡议中担任领导职务， 网络研讨会和其他场所。TCORS将得到宾夕法尼亚州立大学医学中心的支持， 烟草与健康研究，促进和协调各部门的烟草研究 医学院的研究生和研究生培训计划 指导委员会包括在烟草问题上合作多年的教员 烟草控制和跨学科研究。指导委员会将至少每周举行一次会议，以确保 该中心坚持最先进的科学，其综合主题，并提出建议的变化 如果有必要的话。核心将确保所有活动，包括职业发展、试点项目、 重大项目以及与其他TCORS的合作均符合FDA的监管需求及其权威。 根据宾夕法尼亚州立大学TCORS（2014-2019），其中包括许多相同的PI和Co-I，我们已经 在地方和国家一级管理TCORS方面具有丰富的经验。的关键组成部分 核心是监督职业提升和培训核心。我们之前的TCORS有20多名学员， 他们中的许多人已经获得了自己的资金，包括国家卫生研究院的培训赠款， FDA烟草产品中心，或在宾夕法尼亚州立大学或其他地方获得教职。职业 增强培训计划由两名前学员领导，他们现在是教师， 继续培训和职业发展下一代烟草监管科学家。