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所在平台: Udemy |
课程主页: https://www.udemy.com/course/general-considerations-ich-e8r1-for-clinical-studies/
课程评论：没有评论
该课程名为“ICH E8 (R1) 临床研究通用考虑”，旨在通过专家指导，帮助学员掌握在临床研究设计中融入质量文化和最佳实践的方法。 课程的核心内容围绕 ICH E8 (R1) 指南展开，该指南是更新 ICH GCP E6 (R3) 的基础，因此也被视为强制性 GCP 培训的一部分。课程将重点关注以下几个关键方面： * **质量文化与主动设计质量：** 强调在临床试验和药物开发规划中培养质量文化，并主动将质量元素融入设计过程中。 * **识别关键质量因素：** 学习如何识别影响试验质量的关键因素。 * **利益相关者参与与风险管理：** 讲解如何通过比例性、基于风险的方法来适当地让各方参与，并管理可能影响受试者安全和试验数据可靠性的风险。 * **以质量为导向的设计（QbD）：** 传授 QbD 概念，并指导学员如何在临床试验的设计、规划、执行和报告中实际应用 QbD。 * **优化药物开发规划：** 学习如何利用良好的研究设计实践来优化药物开发规划。 * **真实案例分析：** 通过实际案例，对比 QbD 的实施与未实施情况，加深理解。 本课程适合所有希望学习如何在临床研究中设计质量的专业人士。课程内容以小章节形式呈现，方便学员按自己的节奏学习。课程结束后，还将有实践测试来巩固所学知识。 讲师 Vincent 拥有超过 20 年的药物开发经验，致力于帮助学员掌握 QbD 概念，并将其应用于日常实践，最终确保受试者保护、数据完整性和试验目标的达成。
Expert advices on how to promote Quality Culture and Best Practices to Design Quality into your Clinical Studies!This course presents the key concepts outlined in already approved umbrella guideline ICH E8 (R1), serving as the foundation to update ICH GCP E6 (R3), and is therefore part of the mandatory GCP training. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.This course provides an overall introduction to clinical development, with a focus on designing quality into clinical trials and identifying critical factors that impact the quality of the trials in order to facilitate acceptance of data and results by regulatory authorities worldwide. We will emphasize the importance of considering quality throughout the clinical trial lifecycle, from study design and planning to conduct, analysis, and reporting. It highlights the need to manage risks that may impact the safety of study participants and the reliability of trial data, and provides guidance how to do so.During this course, you will learn to implement the quality by design (QbD) concept in the design, planning, conduct and reporting of your clinical trials. This course will help focus on what really matters in order to ensure the protection of study participants, the integrity of the data and reliability and the ability of the studies to meet their objectives. This course complements well the GCP principles that all clinical research professionals must follow.I designed this course based on my 20+ experience in drug development for any clinical research professional seeking to learn how to design quality in their clinical studies and anticipate problems that may occur.Together, I will walk you through the QbD concepts , so that you will be able to apply QbD to your daily practice. We will:Understand the General Quality Principles of Clinical ResearchUnderstand the link between ICH E8 (R1) and ICH GCP E6Learn how to identify Critical to Quality factorsIdentify and understand the ICH E8 (R1) requirements for optimal design and conduct clinical studiesUnderstand and learn how to apply practically the process to implement good design quality into clinical studiesLearn how to utilize good study design practice to optimize drug development planningUnderstand the key elements of the study protocol that may be used to optimize the design of a studyLearn from the experience in real case studies where QbD was implemented Vs not implementedThis course is dedicated to all clinical research professionals willing to learn how to design quality into their clinical studies in line with the ICH GCP principles. To facilitate the learning experience, the course has been broken up on purpose in several small lectures. If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.A final Practice Test at the end of the course will consolidate your knowledge.Feel free to look at the content of the course to know more and contact me any time if you have any questions!Are you ready?I am looking forward to seeing you inside this course!Sincerely,Vincent
