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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-pharmaceutical-products-registration-in-bahrain/
课程评论：没有评论
**课程名称：** 巴林药品注册精通 **课程概述：** 本课程旨在帮助学员掌握在海湾合作委员会（GCC）国家之一——巴林王国的药品注册流程。巴林虽然市场规模不大，但充满机遇。本课程将引导您深入了解巴林医疗保健部（Ministry of Health）的相关规定，并结合实际案例，教授药品注册、更新、变更处理，以及产品分类、参考国家确立、主站注册、CTD/eCTD（M1-M3）准备、基线提交管理、注册表格填写、提交申请管理、跟踪追溯系统、条形码和2D矩阵等关键环节。 **您将学到：** * 巴林国家卫生监管局（NHRA）概览 * 如何选择参考国家 * 主站注册流程 * 药品分类标准 * NHRA监管流程管理 * CTD/eCTD（M1-M3）核心模块准备 * 基线提交管理 * 注册表格的填写与管理 * 药品更新与变更（各种类型）的处理 * 跟踪与追溯系统的应用 * 海关清关、条形码及2D矩阵在货物进口中的应用 * 药物警戒和上市后安全实践 **教学特色：** 本课程以“来自实践”为主题，通过实际案例和模板，带领学员进行监管事务练习，一步步学习注册、更新和变更等操作。课程还将展示实际表格和模板，协助学员共同准备提交文件，确保其有效性，并与实际提交系统进行互动。最终，学员将了解巴林药品进口的清关、跟踪追溯、条形码和2D矩阵等流程，以及药物警戒实践。 **对学员的价值：** 完成本课程后，您将具备在巴林市场进行药品注册的专业知识和实践技能，从而抓住市场机遇，成功将您的药品推向巴林市场。课程最后将对学员掌握巴林药品注册能力表示祝贺，并期待未来在医药行业与各位同事相见。
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 Kingdom of Bahrain.What will you learn?Getting introduction to NHRA Getting introduced to the reference countries sMaster site registration Products classification Manage NHRA Regulatory processCTD/eCTD preparation M1 to M3 Core modules preparation Baseline submission management Prepare registration Forms Manage Renewal/variation Manage Tracking/Tracing In this course, I will take you on an interesting journey with the Ministry of the health of Bahrain, 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 Bahrain, 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, 2DMatrix for all the shipments planned for the kingdom of Bahrain market importation. In addition to pharmacovigilance practice, the after-sale safety practices. 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 kingdom of Bahrain market, and see you soon in the pharma industry my dear colleagues.
