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所在平台: Udemy |
课程主页: https://www.udemy.com/course/materiovigilance-medical-device-vigilance/
课程评论：没有评论
课程名称: 医疗器械监测高级证书 课程概述: 大家好！欢迎来到PV药物安全学院的课程——医疗器械监测高级证书（Materiovigilance）！您是否准备好进一步深入了解医疗器械的安全性和监管合规性？这个综合课程旨在为您提供Materiovigilance（医疗器械监测）的坚实基础，确保您能在这一重要领域中游刃有余。 在本课程中，您将学习Materiovigilance的基本原则，包括其在确保医疗器械安全性和有效性方面的重要性。我们将探讨关键概念，如Materiovigilance法规、MDAE报告及指南、器械召回、基线研究、因果评估、信号检测、严重不良事件报告和上市后监测等。同时，您还将获得关于MDAE和FSCA表格的演示，帮助您掌握在Materiovigilance角色中所需的知识和技能。 本课程的讲师拥有超过12年的药物安全行业经验。无论您是医疗卫生专业人士、监管事务专员，还是希望拓展知识的学员，这门课程都非常适合您！立即加入我们，踏出掌握医疗器械监测（Materiovigilance）的第一步。现在就报名，提高您在医疗器械监测（Materiovigilance）方面的专业素养！ 感谢您的关注， PV药物安全学院
Hello!! Greetings from PV Drug Safety Academy.Welcome to the course - Advanced Certificate in Medical Device Vigilance [Materiovigilance]!Are you ready to deepen your understanding of medical device safety and regulatory compliance? Look no further! This comprehensive course is designed to provide you with a solid foundation in Materiovigilance, also known as Medical Device Vigilance, ensuring that you are well-equipped to navigate the complexities of this critical field.In this course, you will learn the fundamental principles of Materiovigilance, including its importance in ensuring the safety and effectiveness of medical devices. We will explore key concepts such as Materiovigilance regulations, MDAE reporting and guidelines; Recall of device, Baseline studies, Causality assessment, Signal detection, Adverse event reporting and post-market surveillance; Demo of MDAE and FSCA form giving you the knowledge and skills needed to excel in Materiovigilance roles.The trainer of this course has 12+ years of industry experience into Pharmacovigilance.Whether you are a healthcare professional, regulatory affairs specialist, or simply interested in expanding your knowledge, this course is for you! Join us today and take the first step towards mastering Medical Device Vigilance [Materiovigilance].Enroll now and enhance your expertise in Medical Device Vigilance [Materiovigilance]!Thanks and Regards,PV Drug Safety Academy
