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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-pharmaceutical-products-registration-in-egypt/
课程评论：没有评论
**课程名称：** 埃及药品注册大师 **课程概述：** 本课程旨在帮助学员掌握如何将药品成功推向潜力巨大、人口超过一亿的埃及市场。我们将深入探讨埃及药品注册的各个环节，并提供实用的指导和实践经验。 **您将学到：** * 埃及药品监管机构（MOH）和国家药品、化妆品和医疗器械审查局（NODCAR）的介绍 * 价格申报流程 * NODCAR的跟踪与追踪机制 * 药物警戒（Pharmacovigilance） * 注册变更（Variations）的类型及流程 * 埃及独特的市场动态和监管要求 * MOH的注册流程，包括文件提交（仅接受纸质版）、实际文件准备和当地代理（Agent）的合作 * 医疗器械的整个生命周期，从分类、注册清单、注册指南到文件准备和实际案例演练 * 药品续期（Renewal）流程 * 埃及药品分析的特殊性，重点介绍NODCAR的独特分析要求 * 埃及注册和分析中的特有例外情况 **课程亮点：** * 深入了解埃及药品市场的独特性及其监管要求。 * 学习如何准备符合MOH要求的纸质注册文件。 * 掌握NODCAR的分析流程及所需文件。 * 通过实践案例，提升药品注册的实操能力。 * 成为埃及药品注册领域的专家。 **适合人群：** * 希望将药品推向埃及市场的制药企业和相关从业人员。 * 对埃及医疗健康行业和药品监管体系感兴趣的研究者和学生。 **学习方式：** 通过理论讲解、案例分析和实践演练相结合的方式进行学习。 **特别提示：** 埃及MOH目前不采用电子系统，也不支持eCTD。所有注册文件必须是纸质版，并由当地代理通过预约形式亲自提交。NODCAR作为独立的分析机构，其分析流程和文件要求对埃及市场而言独一无二，请务必予以关注。
In this course, we will explore together how can we place our pharmaceutical products in the highly potential market, huge bulky market, the 100 million population market of Egypt.What will you learn?Introduction to EDA Pricing Dossier submission NODCAR Tracing/tracking Pharmacovigilance Variations, its forms and process We will go back to the ancient pharaohs' area and place our pharmaceutical products thereThis would be a very interesting special journey, as the market of Egypt has its own dynamicswhich requires close follow-up to keep an eye on the updates, and also need close relation with your business partners thereWe will be the expert on pharmaceutical products registered with the MOH of EgyptMOH of the republic of Egypt does not have an electronic system for handling regulatory activities, not yet adopted the eCTD system. that is why the MOH of Egypt considers only hard copies, and actual physical dossiers to be submitted personally through your local agent in Egypt with Egypt MOH through prior appointment.In this unique trip, we will cover, the whole life cycle of medical devices starting from classification, passing by the registration checklist, then the registration guidelines, and see how we can prepare these required documents, and forms, let's practice the actual dossier preparation, then we will move to renewal, we will close the pharmaceutical products registration session with the general conditions as a sum-up.Egypt has many exceptions regarding the requirements for either registration or analysis, so please pay attention to these exceptions as they are unique for the market of Egypt only.The analysis part is so special here, as there is a special institution for the analysis, which is the NODCARwhich is physically not in the same place as the MOH as the case with all other health authoritiesThe NODCAR is so unique analysis institution with a unique long list of analysis documentsSo fasten your seat belt and lets' fly to 7000 years back, let's fly to the pharos.
