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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmacovigilance-system-master-file/
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课程名称：药物监测系统主文件（PSMF） 概述： 此课程专为药物监测专业人士、制药学生、医学从业者及生命科学毕业生设计。针对那些在药物监测领域具有个案报告（ICSR）、汇总报告、信号管理或风险管理经验的人，以及希望学习和发展维护药物监测系统主文件（PSMF）职业的人士。本课程将帮助学员掌握PSMF的复杂但具有挑战性的职能，这在药物监测领域是一个高薪职位。 本课程的讲师拥有超过11年的药物监测行业经验，来自不同的跨国公司（MNC），在个案报告、汇总报告、信号和风险管理方面具有丰富的专业知识。 课程内容包括： - PSMF的法律要求及其必要性 - PSMF的注册与维护 - 药物监测系统的表述 - PSMF的结构部分： - QPPV - 许可持有者的组织结构 - 安全数据的来源 - 计算机系统与数据库 - 药物监测流程 - 药物监测系统表现 - 质量系统 - 附件 - 变更控制、日志、版本和存档 - PSMF的呈现格式与布局 通过完成此课程，您将了解“药物监测系统主文件（PSMF）的最佳实践”。欢迎报名加入我们这门激动人心的课程，期待在课堂上见到您。 最好的祝愿， PV药物安全学院
Course Title: Pharmacovigilance System Master File (PSMF)____________________________________________________________________________________________________This course of Pharmacovigilance System Master File (PSMF) is exclusively designed for Pharmacovigilance professionals, Pharma students, Medical practitioners and Life science graduates. This course will be helpful to those who have ICSR, Aggregate Reporting, Signal management or Risk management experience in Pharmacovigilance domain and for those who wants to learn and pursue their career in maintaining Pharmacovigilance System Master File (PSMF). This is one of the high paying Job Role in Pharmacovigilance domain. Pharmacovigilance System Master File (PSMF) is complex but challenging job role in Pharmacovigilance domain.The Trainer of this course has more than 11+ years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR, Aggregate Reports, Signal and Risk Management.In this course we have covered following topics:Legal requirements and need of PSMFRegistration and Maintenance of PSMFRepresentation of Pharmacovigilance SystemsSections of PSMF:- QPPV- Organisational structure of the MAH- Sources of safety data- Computerised Systems and Databases- Pharmacovigilance Processes- Pharmacovigilance System Performance- Quality System- AnnexuresChange control, Logbook, Versions and ArchivalPSMF presentation - Format and LayoutBy completing this course, you will get to know about "Best practices of Pharmacovigilance System Master File (PSMF)".Enroll and join us in this exciting course. See you soon in the class.Best Regards,PV Drug Safety Academy
