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所在平台: Udemy |
课程主页: https://www.udemy.com/course/pharmaceutical-products-registration-united-arab-emirates/
课程评论：没有评论
课程名称：阿联酋药品注册 课程概述：本课程将帮助您成为阿联酋这一高潜力市场的药品投放专家，这里是中东地区的商业中心。您将学习到的内容包括：MOHAP LOA简介、eCTDM1准备、MOHAP电子转型、注册申请流程、续展、变更、较小变更、变更列表、变更表格、附录、追踪与更新等。 课程将提供所有工具，以管理从药品注册到在阿联酋及海湾合作委员会（GCC）地区投放药品的所有监管活动。随后，您还将学习药品上市后的活动，如续展、检查表、申请和“主要/次要”变更，以及药物警戒工作。课程还将从分类入手，这是任何产品在健康管理机构管理上的基本要求。 学习内容包括：如何准备LOA，法律化或公证的相关解释，以及公证国家名单；UAE eCTD实施与文件结构的详细解析；通过在线提交为传统产品准备资料；以及在2016年3月7日前注册的产品需要转换为e-CTD格式。课程还会介绍eCTD软件的使用，例如EXTEDO eCTD Manager和LORENZ DocuBridge等。 此外，课程内容还将涵盖模块1到模块5的结构，其中本地药品注册当局的职责包括对模块3中的稳定性章节进行审核。注册生产场地在产品注册文件提交前是强制要求的，同时需要提供合法化的CPP、GMP和ML等硬拷贝。 课程的最后，您将学习到有关产品追踪和追溯的知识，以及与药品监管局和阿布扎比健康局相关的2D矩阵条形码的实施和要求。 课程将以阿联酋卫生部最新发布的品牌同步指南结束。祝贺您完成了这段学习旅程！希望您在制药行业中取得成功，期待与您再次见面。
This course will prepare you, to be an expert in pharmaceutical products placement in the high-potential market of the United Arab Emirates. the business hub of the Middle East region. What will you learn?Introduction to MOHAP LOA eCTDM1 preparation MOHAP e Transformation MOHAP registration Application process Renewal Variation Minor variation Variation listVariation forms AppendicesTracking/tracing Updates This course will provide you, with all tools that you need to run all regulatory activities related to pharmaceutical products starting from registration, to placing these pharmaceutical products in the high potential diverse market of the UAE, in Dubai, the GCC region business hub. Then to perform post-market placement activities, such as renewal/Checklist/Application and variations "Major/Minor"and variations appendices, in addition to pharmacovigilance.We will take off together to the United Arab Emirates together, starting our journey with the classification, as the basic mandatory step for the regulation of any product ever with any health authority ever. as they do not follow blindly the COO classification.Then we will prepare the LOA, with the explanation of the mandate of either legalization or notarizationWhat is notarization? and the notary list of countries? Then we will transit for a while with UAE eCTD Implementation, and eCTD File Structure, with great focus and deep dive into M1 insights.We will prepare together the dossier for online submission for the conventional products Products registered before 7 March 2016 need to be reformatted to e-CTD format. The MOHAP e-Transformation was implemented by the MOH of the UAE on 11 April 2019 and is still applicable as far as the latest regulations.The eCTD software that you most probably use is either:EXTEDO eCTD Manager (Corporate level). MOH website use.LORENZ DocuBridge (Individual level). for companies and local distributors to use. With the e-CTD file we need to submit:-Letter confirming that the DVD or CD does not contain any virus, validation report. The eCTD structure is as per below:Module 1, Module 2, Module 3, Module 4 & Module 5Module 1:One of the Local DRA responsibilities is to guide the GRA in module 1.Modules 2,3,4,5 from the Global side. One of the Local DRA responsibilities is to Review the Stability section in module 3.For sure the registration of the manufacturing site before/ or in parallel with the product registration file submission is mandatory. With the mandate to provide legalized hard copies of the CPP, GMP, and ML. Then our next short transit will be with the CPP and CEP. what is the difference? each for which finished product or API?Does CEP change considered a variation in the United Arab Emirates? we will see together.And then we will end our interesting journey of by-products Tracking, and tracing with the implementation and the mandate of the 2DMatrix barcode supported by the DHA and Abu Dhabi circulars issued by the subsidiary health entities of Dubai and Abu Dhabi, however, both are working under the umbrella of the MOH of the UAE.Then we will do our landing with the most updated guidelines ever issued by the MOH of the UAE, which is Brand synchronization.Congratulation on our journey completion. I wish you have enjoyed our trip, best of luck to all of you, and see you soon successful in the pharma industry.
