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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-pharmaceutical-products-registration-in-qatar/
课程评论：没有评论
**课程名称：** 掌握卡塔尔药品注册 **课程概述：** 本课程专注于卡塔尔——海湾合作委员会（GCC）国家中最具吸引力的市场之一——的药品注册。尽管市场规模相对较小，但其强劲的市场驱动力和丰富的机遇，为制药企业提供了绝佳的发展空间。本课程将帮助您抓住机遇，成功将您的药品推向卡塔尔市场。 **课程内容：** * **卡塔尔监管体系介绍：** 深入了解卡塔尔的药品监管框架。 * **电子通用技术文件（eCTD）的准备与提交：** 掌握eCTD的制作流程和提交指南，包括卡塔尔的eCTD提交流程、实际eCTD表格的准备以及模块1的分析要求。 * **条形码、追踪与追溯：** 学习在卡塔尔市场实施条形码、追踪与追溯系统。 * **实操演练：** 通过实际案例，进行药品注册、延期和变更（含各类变更）的实操演练。本课程遵循“来源于实践”的教学理念，将为您提供真实的项目经验。 * **文件包准备与验证：** 帮助您准备、验证提交文件包，并与实际提交系统进行互动。 * **清关、追踪/追溯系统、条形码和2D矩阵：** 学习所有与卡塔尔市场进口相关的海关清关、追踪/追溯系统、条形码和2D矩阵的应用。 * **药物警戒与上市后安全实践：** 了解卡塔尔的药物警戒要求和上市后安全管理。 * **地区性监管趋势：** 了解沙特阿拉伯作为地区领导者率先实施的系统，以及阿曼、阿联酋和巴林等国的跟随情况，并预测其他国家的未来发展。 **学习目标：** 通过本课程的学习，您将能够： * 全面掌握卡塔尔药品注册的各项流程和要求。 * 熟练运用eCTD系统进行药品注册文件的准备和提交。 * 理解并实施卡塔尔的追踪、追溯和条形码系统。 * 自信地处理药品注册、延期和变更等事宜。 * 成为卡塔尔药品市场上经验丰富的注册事务专家。 **目标学员：** 希望在卡塔尔市场注册和推广药品的制药行业专业人士，包括注册事务、法规事务、质量保证等部门的同事。 **学完本课程，恭喜您将全面掌握卡塔尔的药品注册，让我们在制药行业再见！**
Master pharmaceutical products registration in one of the most interesting parts of the GCC countries, a relatively small market, mainly driven by the market, full of opportunities, let's grape the opportunity and place our pharmaceutical products there in the market of the state of Qatar.What will you learn?Getting introduced to Qatar regulatory system Master Drug submission eCTD preparation and submission Guidance on Qatar eCTD submission Actual eCTD Forms preparation Module 1 for Qatar Analysis requirements Barcoding Tracking and tracing In this course, I will take you on an interesting journey with the Ministry of the health of Qatar, to master our pharmaceutical products registration there, let's practice regulatory affairs, registration, renewal, and variations with all its types, classification, case by case using actual examples from practice. As I always keep my theme in the pharma academy "It comes to you from practice".In this course, we will cover all topics related to pharmaceutical products in Qatar, which will empower you to master the market. Then we will go deeper to see the actual forms, and templates, as usual, I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, ensure its verification, and interact with the actual system for the submission.and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for the state of Qatar market importation. In addition to pharmacovigilance practice, the after-sale safety practice.The system was first implemented by KSA the leader of the region, and then Oman, UAE, and Bahrain followed so far, and the others are coming soon.And finally, congratulations to you for mastering pharmaceutical products registration in the Oman market and see you soon in the pharma industry my dear colleagues.Let's go
