|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/practical-course-on-pharmacovigilance-aggregate-reports/
课程评论：没有评论
课程名称：药物警戒汇总报告实用课程 课程概述：药物警戒汇总报告是为指定的药品编制和提交安全报告给全球监管机构的重要活动，构成了药品安全监测的基本部分。对于正在开发的分子，需提供特定的开发安全更新报告（DSUR）；而对于已获得市场授权的产品，则需提交定期不良药物体验报告（PADER）和定期安全更新报告/定期效益风险评估报告（PBRER）。基于对全球安全报告的周期性分析，药品标签会进行更新，以优化药品的安全使用。PADER报告需提交给美国食品和药物管理局（FDA），用于在美国获批市场的产品。由于汇总报告的复杂性和监管审查，报告质量已成为全球合规问题。因此，本实用训练课程将帮助行业专业人士应对监管要求，理解药物警戒医疗安全写作的必要方面，并掌握当前的监管框架。 学习目标： 1. 了解国际会议（ICH）E2C和E2F、良好药物警戒实践（GVP模块VII）以及全球接受性中提到的要求。 2. 来源数据收集、报告准备的整个过程以及写作的关键方面，包括行列表和汇总表的准备。 3. 深入了解DSUR、PBRER、RMP和PADER的模板。 适合对象：本课程适合在制药行业从事药物警戒、药物安全、监管和医学写作职位的专业人员。最适合参加此培训的专业人士是新进入医学写作和/或药物警戒职位的初学者，或希望扩展汇总报告专业技能的中级写作/专家。 关键主题： • DSUR：法规、文件格式和内容 • PBRER：法规、文件格式和内容 • 汇总报告的规划和医学写作实践 • RMP：法规、文件格式和内容 • PADER：法规、文件格式和内容 职业机会： 1. 对于初学者，若为生命科学专业毕业生或医疗专业人员，可以在药物警戒领域开始作为药物安全助理/药物安全医生，其角色主要限于不良事件报告（ICSR）处理。 2. 拥有三年经验后，可以加入信号管理或汇总写作/药物警戒医学安全写作团队。 3. 在药物警戒过程中，团队中将有两个角色，一为医疗专业人员，另一为医生。 4. 拥有药物警戒认证和五年以上经验者，可以申请管理职位。 5. 还可以根据兴趣和经验选择其他角色，如质量保证和质量控制团队、药物警戒数据库管理员等。
Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development called development safety update reports while Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports/Periodic Benefit-risk Evaluation Reports (PBRERs) are submitted for products with marketing authorization. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. PADERs are aggregate safety reports to be submitted to the Food and Drug Administration (FDA) for products approved for marketing in the United States (US). Quality of aggregate reports became a major compliance issue globally due to their complexity and regulatory scrutiny. This practical training course in writing aggregate reports will help industry professionals to keep up with the regulatory requirements. This training will help to understand the essential aspects of pharmacovigilance medical safety writing as per current regulatory framework. Learning objectives: 1. Will learn about the requirements mentioned in ICH E2C and E2F, good pharmacovigilance practices (GVP module VII), as well as global acceptability. 2. Source data collection, whole process of report preparation and critical aspects of writing, preparing line listings and summary tabulations. 3. In depth knowledge on template of DSUR, PBRER, RMP, and PADER. Who will attend: This course is intended for the professionals working within the pharmaceutical industry In pharmacovigilance, drug safety, regulatory, and medical writing positions. Professionals Most likely to benefit from this training are newcomers to the medical writing and/or Pharmacovigilance positions or writers/specialists with intermediate level of experience who Wish to extend their professional skills in aggregate reports.Key Topics: • DSUR: regulations, format and content of the document• PBRER: regulations, format and content of the document• Practical aspects of planning and medical Writing related to aggregate reports• RMP: regulations, format and content of the document• PADER: regulations, format and content of the documentCareer opportunities: 1. As a fresher one can start their career in pharmacovigilance as drug safety associate/drug safety physician if you are a life science graduate or HCP. The role of Drug safety associates is mainly limited to ICSR processing. 2. With three years of experience you can be a part of signal management or aggregate writing/ PV medical safety writing teams. 3. For any team in pharmacovigilance process there will be two roles will be there one for other HCPs and one for Physicians. 4. With certification in pharmacovigilance and 5+ years of experience one can apply for management roles. 5. There are also other roles like QA and quality control teams, database admin in pharmacovigilance, based on interest and experience one can choose these positions.
