|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/an-overview-of-pharmacovigilance/
课程评论：没有评论
Coursera 课程《药物安全与药物警戒基础精通》概述 本课程致力于提供药物警戒（Pharmacovigilance）的全面概览。药物警戒活动通过检测、评估、理解和预防药物不良反应，对患者安全至关重要。技术的实施和系统的构建能够简化药物警戒操作，提高生产力并为企业节省成本。 课程内容涵盖： * **药物警戒的历史渊源**：追溯药物警戒的发展历程。 * **监管组织的职责**：阐述各监管机构在药物警戒中的作用。 * **关键术语与定义**：解释与不良事件（Adverse Event）和药物不良反应（Adverse Reaction）相关的各种术语和定义。 * **药物警戒组织的核心流程**：详细介绍药物警戒组织的完整运作链条，包括： * **病例接收 (Case Intake)** * **病例处理 (Case Processing / Data Entry)** * **信号管理 (Signal Management)** * **汇总报告 (Aggregate Reporting)** * **风险管理 (Risk Management)** * **行业驱动和颠覆性因素**：探讨影响药物警戒行业的关键因素，如战略、外部环境、技术等。 **课程目标：** 本课程旨在为学习者提供药物警戒的基本知识，并为进一步深入学习奠定基础。通过练习和测验题，检验学习者的学习进展。 **适合人群：** * 对学习药物警戒领域技术和系统感兴趣的药物警戒专业人士。 * 为药物警戒运营开发软件的 IT 专业人士。 * 生命科学领域，寻求在药物警戒技术领域职业转型的人士。 * 希望扩展知识面的药学专业的学生。 **重要提示：** 本课程为理论性质，仅用于教育目的。它为您探索该主题提供了路径。实际工作场景可能与课程内容有所不同，在将任何概念应用于工作场所时，请务必谨慎并进行尽职调查。
This course is designed to teach an Overview of Pharmacovigilance. Pharmacovigilance activities are critical to safety of patients by detecting, assessing, understanding and preventing adverse reactions. Implementation of technology and building systems that can simplify the Pharmacovigilance operations, bring productivity gains and save costs for the companies.This course starts with historical aspects of Pharmacovigilance, the role of Regulatory Organizations various terms and definitions related to an Adverse Event and Adverse Reaction.The core part of the course is the entire chain of activities for a Pharmacovigilance Organization. This starts with Case Intake, Case Processing (Data Entry) Signal Management, Aggregate Reporting and Risk Management aspects.The concluding part of the course talks about all those enabling and disrupting elements of the industry like Strategy, External environment, Technology etc.Overall, the course attempts to provide the learner an opportunity to learn the very basics of Pharmacovigilance and expand thereafter. Exercises, Quiz questions are designed to test the learner's learning progress. This course can be taken up by· PV Professionals interested to learn Technology and Systems in PV domain· IT Professionals building software for PV Operations· Anyone in Life Sciences domain and looking for a career shift technology in PV· Pharmacy students to expand their knowledge base Please note that this course is theoretical in nature and for educational purpose only. This provides a path for you to explore the subject further. The real time scenarios in your Organization can be very much different. Kindly take cognizance and perform due diligence while applying any of the concepts. directly in your workplace.
