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所在平台: Udemy |
课程主页: https://www.udemy.com/course/register-your-pharmaceutical-products-in-kuwait/
课程评论：没有评论
**课程名称：** 科威特药品注册大师 **课程概述：** 本课程将带您深入了解如何在潜力巨大的科威特市场成功注册药品。科威特是一个以招标为主导的小型市场，其药品监管流程与其他国家相比独具特色，简单明了。 **您将学到：** * 科威特卫生部（MOH）介绍 * 机构注册、产品注册、稳定性测试、续期和撤销流程 * CTD 模块（M1, M2, M3）解析，重点关注 M1 指南下的 CTD 结构 * 成品注册、变更以及药物警戒（PV）更新 * 合格递交所需文件和表格的准备 * 实际的药品注册文件（dossier）准备实践 * 科威特药品注册的总体条件和总结 * 稳定性要求详解 * 药物警戒（PV）的最新和严格要求，这不仅适用于科威特，也适用于所有海湾合作委员会（GCC）国家。 **课程特色：** * **无电子系统：** 科威特卫生部目前没有电子系统处理监管活动，也不支持 eCTD。所有注册均需提交纸质文件，并通过当地代理人亲自递交。 * **实践性强：** 课程将涵盖从分类、注册清单、注册指南到文件准备和实际文件制作的全过程。 * **聚焦重点：** 课程将重点关注稳定性要求和最新的药物警戒（PV）要求。 * **简短高效：** 课程为期约 2 小时，旨在帮助您在短时间内成为科威特药品注册专家。 **学习成果：** 完成本课程后，您将成为科威特卫生部注册药品方面的专家，能够独立完成药品在科威特的注册流程。
In this course, we will explore together how we can place our pharmaceutical products in the highly potential market of Kuwait, a relatively small market driven by tenders.What will you learn?Introduction to Kuwait MOHSite Registration Product Registration Stability RenewalCancellation CTD M1M2M3 Quality MOH circulars Ministerial decrees CTD structure as per M1 guidelines The Finished product Variation PV Updates We will be the experts on pharmaceutical products registered with the MOH of KuwaitThis journey is so unique compared to other regulatory journeys of other countries, as it is so simple, and straight to the point.MOH of the state of Kuwait does not have any electronic system for handling regulatory activities and has not yet adopted the eCTD system. That is why the state of Kuwait of MOH considers only hard copies and actual physical dossier to be submitted personally through your local agent in Kuwait with Kuwait MOH through prior appointment.In this short course, we will cover, the whole life cycle of pharmaceuticals starting from classification, passing by 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 pharmaceuticals registration session with the general conditions as a sum-up, then we will end our journey we will dive deeply into the stability requirements, with great focus on highly demanding, most updated circulars of the pharmacovigilance and its wake up call which is not limited to the state of Kuwait only but also to all other GCC countries.So fasten your seat belt for this short joyful tripthat we will land in Kuwait on a 2 2-hour flight we will return from this flight as experts in pharmaceutical products registered with the state of Kuwait.So let's take off.
