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所在平台: Udemy |
课程主页: https://www.udemy.com/course/register-healthcare-products-centrally-in-the-gcc-by-sfda/
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课程名称：通过SFDA在海湾合作委员会 (GCC) 中央注册医疗产品 课程概述：中央注册是制药行业中最受关注的话题之一。这个话题长期以来一直备受讨论，并在2021年得到正式实施。通过海湾卫生理事会（GHC）进行的医疗产品中央注册，已经适用于药品，并很快将扩展到医疗器械。 您将学习到的内容包括： - 中央注册流程介绍 - GCC各国的监管法规 - 课程模块1至模块5的详细内容 - 现场提交 - 市场授权的中央续展 - 中央变更及其清单 - 中央产品说明书（SMPC）和患者信息手册（PIL） - 中央注册的稳定性测试 - 中央注册的储存与运输 作为一名法规事务专业人士，您必须随时了解变化的法规，尤其是在中东和北非（META）地区。中央注册选项使您能够仅通过一次提交和一个文件，即可在所有其他GCC国家获得批准。这种高效化的注册流程大大缩短了审批时间，从一年缩短到仅两个月。 课程强调，中央注册是制药行业的强制要求，因为在GCC地区，必须拥有中央注册才能申请投标。我们将详细讨论与中央注册相关的所有主题，包括海湾药物注册中央委员会、药品中央注册流程、公司（场地/MAH）中央注册、市场授权续展和变更要求的指导方针、活性药物成分（API）和成品（FPS）的稳定性测试标准等。 让我们一起掌握中央注册的知识。
Central registration is the most updated ever pharma industry interesting topic. The topic has been always on the table for discussion, many times ago till it was enforced finally in 2021.The central registration through the Gulf Health Council "GHC" for pharmaceutical products so far, and very soon will be applicable also to medical devices.What will you learn?Introduction Central Registration Process Regulatory Aspects of the GCC Countries Module 1 in detail Module 2 in detailmodule 3 in details Module 4 and 5 Module 3 insights Site Submission Central Renewal of Marketing Authorization Central VariationCentral Variation List Central SMPC/PIL Stability testing of central registration Storage transportation f central registration As a regulatory affairs professional you must keep up to date with the changing regulations, especially in the META regionThe central registration option allows you to make only one single submission, one single dossier for your product, that will be approved in all other GCC countries, so going central, means going to the whole GCC region by only one submission.Still, you have to submit it individually to each country, but it is just admin work, and the dossier has already been revised and proven by the Gulf Health Council, so it takes 2 months instead of 1 year, does that sound great? for sureHowever, soon you will not have to submit individually anymore after the central registration submissionCentral registration is mandatory for the pharma industry business as it is not allowed to apply for the tenders in the GCC region unless you have central registration, those tenders cannot be missed for any company to achieve the potential ROI.In this course, we will cover everything related to the topic of the central registrationStaring by Gulf Central Committee For Drug Registration, Human Drugs Centralized Registration Process, Module 3 insights, Company (Site/MAH) Centralized Registration, GCC Guidelines for Renewal of Marketing Authorizations, GCC Guidelines for Variation Requirements, GCC Guidelines for Variation Requirements, GCC Guidelines for Presenting the SPC, PIL and Labeling Information, GCC Guidelines for Stability Testing of Active Pharmaceutical Ingredients ( API) and Finished Products ( FPS), GCC Guidelines for the Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products, and finally the central site audit.Let us master central registration together.
