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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceuticals-registration-ksa/
课程评论：没有评论
课程名称：沙特阿拉伯药品注册大师课程 课程概述：本课程将为您提供在海湾合作委员会（GCC）地区最大且最重要的市场中掌握药品的所有必需知识、技能和实践经验。沙特阿拉伯的药品市场是任何寻求可观投资回报和实现预期收入的制药或医疗保健公司不可错过的市场。 您将学习到的内容包括： 1. SFDA（沙特食品药品监督管理局）分类指南简介 2. 药品注册指导 3. eCTD（电子通用技术文档） 4. eCTD M2到M5模块 5. 申请流程 6. 模板与CPP（优先药品申请） 7. 特殊注册方法 8. SMPC（汇总药品信息）注册费用 9. 追踪/追溯系统 10. 清关流程 课程结束时，您将成为药品注册、续期和变更的专家。我们将从沙特阿拉伯的分类开始，聚焦于分类与原产国（COO）及SFDA的具体不匹配情况，这些案例在过去五年中日益增多，与之前及其他卫生机构相比有所不同。此分类主题极为关键，您将在实践中学习如何处理这些常见案例。 接着，我们将共同探索eSDR系统，了解药品注册流程的工作流，并深入研究eCTD的结构、模块及每个模块的检查清单，学习如何准备每个模块所需的表格和模板。要特别强调的是，模块1不属于任何eCTD，而您将学习如何为沙特阿拉伯的SFDA申请准备特定的模块1。 我们还将解释两种非常具体的注册途径：简化途径和验证途径，每种途径都为注册提供了快捷的解决方案，课程将结合实践进行探讨。SMPC和患者信息手册（PIL）将根据最新版本、模板及适用于其他GCC国家的SFDA布局进行详细讲解。 随后，我们将快速了解注册费用和最终注册证书的获取流程，以及如何在续期和变更时维护注册证书的有效性。我们将探讨追踪/追溯系统的演变，从线性条形码转向2D矩阵条码，以及SFD实施的聚合新系统，这一最新话题很快将在其他GCC地区推广，阿联酋已经在沙特之后直接采用了此系统。 最后，我们将结束在沙特阿拉伯的学习之旅，介绍SFD的清关系统“IBRCS”及药物警戒（PV）要求。让我们开始在沙特市场掌握制药产品的旅程，成为未来制药行业的专业人士和管理者，共同开启成功的故事。
This course will provide you with all the required knowledge, and skills, in addition to the experience from practice to mastering pharmaceutical products in the biggest and most important market ever in the GCC region, the market that could not be missed by any pharmaceutical or healthcare company seeking for a considerable ROI, and achieving the required revenueWhat will you learn?Introduction to SFDA Classification guidelines Guidance for pharmaceutical registration eCTDeCTD M2 to M5Application processTemplates CPPSpecial approaches for registrationSMPCS Registration fees Tracking/tracingClerance By the end of this course, you will be the expert on pharmaceutical products registration, renewal, and variations We will start our journey towards the market of Sudi Arabia by the classification, focusing on the specific situations to classification mismatch between COO and SFDA of Sudi Arabia, these cases which became too many over the past 5 years, not like before, not like other health authorities which usually follow the COO classification.and this topic of classification is so critical, so in this course, you will learn from practice how to proceed with these quite common cases.Then we will go together to the eSDR system to see how the workflow of the pharmaceuticals registration processExploring the eCTD, structure, modules, and checklist of each module, how to prepare the forms and templates that should be there in each module, keep emphasizing again that module 1 is not part of any eCTD, and how to prepare module 1 that specific for SFDA submission in the KSA. Then we will explore what is new in these regulations of the SFDA submission, and the drug application process itself.Afterward, we will explain 2 very specific registration pathways, the Abridged and Verification pathways, each of them will provide a shortcut pathway for the registration, so we will explore these together, these 2 pathways are from practice.The SMPC and PIL are explained in this course in detail as per the latest versions, templates, and SFDA layouts which are acceptable in all other GCC countries as well, we will learn together how to prepare these SFDA-approved layouts.Then we will go through fast flight to the registration fees and finally have a look at the final registration certificate, then how to keep it by renewal and variations if any, when and how to prepare for each of them. Then we will move to the next step of the tracking /tracing system and see the shift from the linear barcode to the 2DMatrix barcode, in addition to the new system set by the SFD for the Aggregation, the most updated topic ever, which soon will be applicable in other GCC regions as well, actually, the UAE started with it directly after the KSA.We going to end this interesting journey in the KSA by the clearance system of the SFD "IBRCS" and the PV requirements.So let us start our journey towards mastering pharmaceutical products in KSA market my dear future pharma industry professionals and managers.Let us start our success story.
