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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-trial-regulation-eu-5362014-in-clinical-research/
课程评论：没有评论
**课程名称:** 欧盟临床试验法规536/2014在临床研究中的应用 **课程概述:** 本课程旨在帮助临床研究专业人员（包括申办方、CRO组织、研究机构及研究人员）深入理解和掌握欧盟临床试验法规（CTR 536/2014）。该法规于2023年1月31日生效，取代了之前的指令2001/20/EC，旨在统一欧盟各国的临床试验流程，并通过临床试验信息系统（CTIS）简化临床试验的审批过程。 **课程亮点:** * **法规概览:** 全面了解在欧盟开展临床试验的CTR法规。 * **变革原因:** 学习为何需要对指令2001/20/EC进行更新。 * **时间线与过渡:** 掌握CTR的引入和过渡期时间表。 * **关键术语:** 理解CTR下的核心定义。 * **CTIS系统:** 了解CTIS的设置和临床试验的提交流程。 * **评估与决策:** 学习CTR下的临床试验验证、评估和决策过程。 * **方案修订与新成员国提交:** 掌握方案重大修订和在研研究中添加新成员国的提交流程。 * **安全及其他报告义务:** 识别相关的安全和其他报告职责。 * **风险与挑战:** 掌握CTR在申办方组织中可能带来的风险和挑战。 * **高层提交规划:** 学习CTR下的高层提交规划。 **讲师:** Dr. Vincent Baeyens 拥有超过20年的全球及中型制药和生物技术公司临床试验经验。 **学习形式:** * 课程内容以短讲座形式呈现，方便初学者学习。 * 进阶学习者可调整讲座播放速度。 * 包含测验和作业，以检验学习成果。 **重要提示:** 本课程不深入探讨CTIS的技术细节，但会提供相关资源链接。 **更新内容:** * 2024年11月: 更新了讲座2的关键事实。 * 2024年1月: 更新了讲座14 - CTIS培训资料目录。 * 2023年3月: 更新了EMA培训文件及讲座14；新增了CTIS/CTR查询管理工作组提供的问答文件（讲座15）。
Updates:[November 2024]: Lecture 2: Updated key facts[January 2024]: Lecture 14 - CTIS Training material catalogue updated with latest information[March 2023]: Training document material from EMA updated and lecture 14 updated accordingly; New Q & A document from the CTIS/CTR query management working group attached (lecture 15)--On 31st January 2023, the Clinical Trial Regulation (CTR) 536/2014 came into force in the European Union (EU) and repealed the Clinical Trials Directive 2001/20/EC. With this Regulation, the EU harmonises the procedures for carrying out clinical trials across the EU states and simplifies the clinical trial approval process through a Clinical Trials Information System (CTIS).This course provides clinical research professionals in Sponsor and CRO organizations as well as investigational sites and study staff with an essential understanding of the CTR to help implement and comply with it.The programme highlights the most important of these key requirements and how these are impacting all EU as well as non-EU sponsors conducting clinical trials in the EU.My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma and Biotech settings.Benefits of attending this course include:Gain an overview of the Clinical Trial Regulation (CTR) to conduct trials in the EUUnderstand why changes to the Directive 2001/20/EC were madeLearn and understand the timeline for CTR introduction and transition periodLearn the essential definitions of terms under the CTRUnderstand how the Clinical Trials Information System (CTIS) is set upUnderstand the submission process of clinical trials in the CTISUnderstand the validation, assessment and decisions process of clinical trials under the CTRLearn the process to submit a Substantial Modification of the protocolLearn the process to submit a new Member State in an ongoing studyIdentify the safety and other reporting obligationsGrasp the risks and challenges associated with the CTR in sponsor organizationsPrepare a high-level submission planning under CTRQuizzes and assignments are proposed along your journey to test your knowledge.To facilitate the learning of beginner students, the course has been broken up on purpose in small lectures. If you are a more advanced student, you can increase the speed of lecture to learn the course at your desired pace.Important remark: Please note that this course does not go into the technicalities of the CTIS. References to adequate resources on the topic are provided.Feel free to look at the content of the course to know more and contact me any time if you have any questions!I am looking forward to seeing you inside the course!Sincerely,Vincent
