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所在平台: Udemy |
课程主页: https://www.udemy.com/course/periodic-benefit-risk-evaluation-report-pbrer-with-template/
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课程名称：周期性收益-风险评估报告(PBRER) - 带模板 课程概述：本课程专为从事药物安全监测(Pharmacovigilance)的不良事件案例管理(ICSR)专业人士设计，旨在帮助他们学习和探索药物安全监测的其他领域，特别是如何从ICSR转向撰写汇总安全报告。在药物安全监测中，周期性收益-风险评估报告(PBRER)是一种全球认可的主要汇总安全报告类型，用于定期评估市场上药品的收益风险特点。课程中将解释PBRER的各个部分，提供所需的基本内容，并利用我们的PBRER模板教授写作原则。我们的社区专家将作为汇总安全报告的主讲人，分享其在撰写各种药物安全报告和项目管理方面的丰富经验。 课程内容包括： 1. 在进入PBRER概念之前，复习汇总安全报告的基础知识。 2. 提供PBRER的理论背景，包括目标、原则、报告部分等，以便在深入每个报告部分之前进行高层次概述。 3. 深入学习PBRER的核心部分，包括每个部分及其子部分的关键内容和撰写概念。 4. 完成主要课程后，介绍PBRER评估报告以及PSUSA程序的关键概念，以提供反馈给MAH提交给EMA的PBRER。 5. 最后，提供一些项目管理技巧的额外讲座，这些技巧对于PBRER的撰写至关重要，包括作者、审查、提交的流程，及与主要利益相关者的战略会议等。 完成本课程后，您将掌握汇总安全报告的基本概念，包括撰写PBRER的主要目标和原则。这将增强您在汇总安全报告领域转变职业的信心，并帮助您顺利应对相关职位面试。我们祝愿所有学习者实现他们的职业梦想！
This course is designed exclusively for professionals working in Pharmacovigilance ICSR Case management, aspiring to learn and explore other domains of PV, especially to shift their careers within PV from ICSR to writing aggregate safety reports.In Pharmacovigilance, Periodic Benefit-Risk Evaluation Report [PBRER] is a major aggregate safety report type which is accepted worldwide for periodic assessment of benefit risk profiles for the medicinal products that are in market.Each section of PBRER is explained with required fundamental content and utilised our PBRER Template to teach the drafting principles of PBRER.One of the experts in our community is a lead-trainer for the aggregate safety reports who has significant experience in drafting various kind of safety reports in pharmacovigilance, including project management. Our SME in this domain will take you through the PBRER concepts using template for your better understanding.You will learn following concepts in this course:We will brush you with the basics of aggregate safety reports before starting PBRER conceptsWe will provide theoretical background to PBRER [objectives, principles, report sections etc] to have a high-level overview before deep diving into each section of the report.Now, you will enter into core section of the course, where you will learn each section and subsections of PBRER, including the key content and drafting concepts of PBRER.After completion of our main part of course, we will explain what are PBRER - Assessment Reports and key concepts of PSUSA procedure in providing feedback to the PBRERs submitted by MAHs to the EMA.At the end, we will provide bonus lectures by giving some project management tips that are essential for production of a PBRER which included general workflows of authoring, review, submissions, strategy meetings with key stakeholders etc.After completion of this course, you will gain new skill in fundamental concepts of aggregate safety reports including the key objectives and principles of drafting a PBRER. With that you can be confident to shift your career into this domain by facing interviews in Aggregate Safety Reports.Our Best Wishes to all learners to realise their professional dreams in their career!
