|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-iso-14155-of-medical-devices/
课程评论：没有评论
**课程名称：** 医疗器械领域良好临床实践ISO 14155 **课程概述：** 本课程是一门全面的ISO 14155医疗器械临床研究良好临床实践（GCP）课程，旨在为研究者、协调员、申办方、临床项目经理、监查员以及其他需要了解GCP知识以成功执行医疗器械临床试验的从业人员提供专业、详细的培训。课程内容将紧跟ISO 14155标准的最新修订，确保学员掌握前沿知识。 主讲人Vincent Baeyens博士拥有超过20年的全球及中型制药、生物技术公司临床试验经验，并在CRO管理、预算和风险管理方面具有深厚专长。 **课程要点：** * **理解ISO GCP要求：** 学习如何在人体中进行医疗器械的临床试验规划和执行。 * **关键干系人职责：** 明确研究者、申办方和伦理委员会各自的角色和责任。 * **课程结构：** 课程被分解为多个小节，方便初学者学习。 * **支持法规检查和审计：** 课程将帮助学员为成功的法规GCP检查和审计做好准备。 * **核心内容：** * 什么是医疗器械 * ISO 14155法规框架 * 临床研究中常见的ISO GCP审计和检查发现（申办方/研究者） * ISO 14155的范围 * ISO 14155良好临床实践原则 * 如何有效规划临床研究 * 进行临床研究的关键步骤 * 为应对审计和检查需要关注的重点 * 反思ISO 14155 GCP的潜在偏离及可能的行动计划 * **学习收获：** 学员将逐步掌握ISO 14155 GCP，并深入理解其精髓。 * **特别说明：** 出于版权原因，课程不提供ISO 14155标准的副本。课程最后设有综合性小测验以巩固知识。 * **互动性：** 学员可以随时查看课程内容，并通过提问与讲师互动。讲师将在课程期间亲自解答学员的问题和评论。 **讲师：** Vincent Baeyens博士
Welcome to this complete edition of the ISO 14155 GCP course on Clinical Investigations with Medical Device!This course offers the first professional, detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials with Medical Devices. This GCP course is maintained up-to-date with upcoming revisions as they become available.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. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight, budgeting and Risk Management. In this course, you will be able to understand ISO GCP requirements to plan, conduct, clinical trials with Medical Devices in humans. We will review the role and responsibilities of the key stakeholders.To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.This course will provide you with a strong support to prepare for successful regulatory GCP inspections and audits.I will lead you step-by-step through the ISO 14155 GCP, and you will learn and understand:What is a Medical DeviceRegulatory framework of ISO 14155Common ISO GCP audit and inspection findings in clinical investigations (sponsor/investigator)Scope of ISO 14155ISO 14155 Good Clinical Practice principlesThe responsibilities of ethics committees, principle investigators and sponsorHow to effectively plan a Clinical InvestigationWhat are the key steps to conduct a Clinical InvestigationWhat to focus upon in order to be audit and inspection-readyReflect upon potential deviations to ISO 14155 GCPs and possible action planPlease note that, for copyright reasons, I am not allowed to share the copy of the ISO 14155 norm. A final Quiz 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!I am of course available personally during the course as well to answer your questions or comments!I am looking forward to seeing you inside the course!Sincerely,Vincent
