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所在平台: Udemy |
课程主页: https://www.udemy.com/course/meddra-training-certificate-course/
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**课程名称：** MedDRA 培训认证课程 **课程概述：** 本课程专为临床研究专业人士、药学专业学生、医学从业者和生命科学毕业生设计，旨在深入介绍和培训国际通用的监管活动医学词典 (MedDRA)。MedDRA 是一个经过临床验证的国际医学术语集，广泛应用于监管机构和受监管的生物制药行业。掌握 MedDRA 是临床研究领域一项高技能的职业要求，相关职位职责复杂且充满挑战。 **讲师资历：** 授课讲师拥有超过 11 年的药物警戒行业跨国公司 (MNC) 工作经验，在個別安全性案例报告 (ICSR) 处理、汇总报告、信号和风险管理方面拥有丰富的专业知识。 **课程重点内容：** * MedDRA 的介绍、目的和基础知识 * MedDRA 代码 * 多轴术语 * MedDRA 词典的层级/结构 * MedDRA 的重要特性 * MedDRA 的优势和局限性 * 标准化 MedDRA 查询 (SMQ)：结构、狭窄和广泛搜索、算法 SMQ、益处与局限性、应用 * MTS：PTC [MedDRA 术语选择：注意事项] * MedDRA 的维护、WebCR、MedDRA 工具和 IME 列表 * MedDRA Web 浏览器演示 **学习目标：** 完成本课程后，学员将能够全面理解 MedDRA 的工作原理。 **立即报名，开启您的 MedDRA 学习之旅！** **敬请期待在课堂上与您相见！** **制作方：** PV Drug Safety Academy
The Medical Dictionary for Regulatory Activities (MedDRA) is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry.This course of "MedDRA Training Certificate Course" is exclusively designed for Clinical Research professionals, Pharma students, Medical practitioners and Life science graduates. This is one of the highly skilled Job Role in Clinical research. The roles and responsibilities of this role are complex and challenging.The Trainer of this course has more than 11+ years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR case processing, Aggregate Reports, Signal and Risk Management.In this course we have covered following topics:Introduction, Purpose and Basics of MedDRAMedDRA CodesMulti-Axial TerminologyMedDRA Dictionary Hierarchy/ StructureImportant Features of MedDRAMedDRA: Strengths and LimitationsStandardized MedDRA Queries (SMQ): Structures, Narrow and Broad Searches, Algorithmic SMQs, Benefits and Limitations, ApplicationsMTS: PTC [MedDRA Term Selection: Points to Consider]MedDRA Maintenance, WebCR, MedDRA tools and IME ListMedDRA Web Browser DemoBy completing this course, you will be able to know how MedDRA works.So, what are you waiting for? Enroll and join us in this exciting course. See you soon in the class.Thanks & Regards,PV Drug Safety Academy
