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所在平台: Udemy |
课程主页: https://www.udemy.com/course/certificate-course-in-pharmacovigilance-practical-icsr/
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Coursera 课程总结：药物警戒实践 ICSR（个体化学药物不良反应报告）证书课程 本课程是您在药物警戒领域的进阶学习，将重点关注个体化学药物不良反应报告（ICSR）的实际案例分析。 **课程目标：** * 将理论知识应用于实际 ICSR 案例处理，提升您的实操能力。 * 为您的职业生涯成功奠定坚实基础。 **课程收益：** * **学以致用：** 掌握将理论 ICSR 概念应用于实际案例的技巧。 * **职场助力：** 作为一门发展型课程，助您在工作中取得成功。 * **实战演练：** 通过实际案例和 MedDRA（医学词典，用于标准化医学术语）的实操演示，加深理解。 * **批判性思维：** 培养对案例的逻辑思考和批判性评估能力。 * **案例优先级排序：** 学习如何对不同紧急程度的案例进行优先级排序。 **课程内容：** 1. **ICSR 导论：** * 案例有效性判断 * 重复性案例查找 * 事件选择与 MedDRA 编码（包括药物警戒的医学词典） * 严重性评估 * 标签评估 * 因果关系评估 * 报告撰写（Narrative writing） 2. **ICSR 实践案例：** * 案例有效性判断实例 * MedDRA 实践操作 * 严重性评估案例分析 * 标签评估案例分析 * 因果关系评估案例分析 * 报告撰写范例 3. **案例优先级排序规则：** * 不同监管机构的提交时限 **授课讲师：** Ramya 女士拥有超过 10 年的药物警戒领域经验，专长于 ICSR 处理、文献检索、信号评估和汇总报告撰写。
This course is continuation to our Basic ICSR course, In this course we will mainly focused on Practical case scenarios.Practical ICSR: A development Course to set you up for success at work.Trainer Ramya Mam has 10+ years of Experience in Pharmacovigilance. She was expertise in ICSR Processing, Literature search, Signal assessment and aggregate writing.What we will talk about in this course is- Introduction to ICSR- Our Training Objective- Training benefits- Topics covered in this course- Summary of key learnings- Checking for understandingOur Training objective: - This is development course to include practical case scenarios of ICSR and guide to apply theoretical concepts into practice.Training benefits:- Apply theoretical ICSR concepts into practical case scenario.- A development course to set you up for success at work.- Practical case scenarios with live MedDRA access.- Logical thinking and critical evaluation of cases.- case prioritization.Topics covered in this coursea) Introduction to ICSR- Case Validity- Duplicate search- Event selection and coding with MedDRA- seriousness assessment- Labelling assessment- Causality assessment- Narrative writingb) Practical case scenarios- Examples of case validity- MedDRA practical- Case scenarios for seriousness assessment- Case scenarios for Labelling assessment- Case scenarios for causality assessment- Sample narrative writingc) Case prioritization rules- Regulatory authority submission timelines
