|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-pharmaceutical-products-registration-in-the-levant/
课程评论：没有评论
课程名称：掌握黎凡特地区的药品注册 课程概述： 本课程旨在帮助学员深入了解黎凡特地区（主要以约旦为主导的地区）药品注册的相关流程和法规。黎巴嫩和叙利亚的药品和医疗设备监管均遵循约旦食品药品管理局（JFDA）的指南，而JFDA又依据沙特阿拉伯食品药品管理局（SFDA）的标准。 学习内容包括： 1. 黎巴嫩药品注册文档及流程 2. 叙利亚药品注册文档及流程 3. 药品进口至黎巴嫩的规定 4. 药品进口至叙利亚的规定 5. 快速通道产品批准流程 6. 特定类别产品的特殊批准 7. 黎巴嫩和叙利亚的产品定价策略 8. 随时关注最新的法规更新 课程将重点关注黎巴嫩公共卫生部（MOPH）对所有药品的注册监督，介绍药品注册技术委员会（TC）如何审核申请以确保符合国家标准。同时，课程还将讲解叙利亚卫生部（MoH）对外国药品公司的注册要求，以及与当地代理商的分销协议。 此外，课程将介绍美国阿拉伯商会提供的支持服务，以帮助制药公司在叙利亚合法化组织并进行药品的认证与注册。 最新更新也将成为课程的重要内容，特别是受海湾合作委员会（GCC）先前实施的法规影响的黎巴嫩公共卫生部的动态变化。这些变化要求学员不断监测并调整，以确保能成功将药品投放到黎巴嫩市场。 总之，尽管黎巴嫩和叙利亚的监管基础相似，均源于JFDA，但各自的监管环境具有独特性，因此需要采取量身定制的注册策略。 欢迎加入我们的课程！
Master pharmaceutical products registration in the levant, the part of the world driven by Jordan from a regulatory point of view, as both Lebanon and Syria are following the JFDA of Jordan for the regulation of both medical devices and pharmaceutical products, and consequently JFDA is following SFDA of Saudi Arabia.What will you Learn?Pharmaceutical products registration documentation- process in Lebanon Pharmaceutical products registration documentation- process in Syria Products importation to Lebanon Products importation to Syria Fast track products approvals Special approvals for specific categories of productsProdcuts pricing in both countries Stay tuned with the recent updates LebanonThe Ministry of Public Health (MOPH) oversees the registration of all pharmaceutical products, encompassing both locally manufactured and imported drugs. The Drug Registration Technical Committee (TC) within the MOPH meticulously reviews each application to ensure compliance with national standards. Engaging with local regulatory consultants can facilitate understanding and adherence to these requirements.SyriaThe Ministry of Health (MoH) is responsible for the registration of pharmaceutical products in Syria. All foreign pharmaceutical firms and their products must be registered with the MoH before they can be marketed in the country. Distribution agreements between international pharmaceutical companies and local agents are regulated by the General Foreign Trade Organization.The US Arab Chamber of Commerce offers services to assist pharmaceutical companies in legalizing their Certificates of Pharmaceutical Products for Syria. These services include document review and certification, embassy liaison, legal consultation, and notarization services.Recent updates within the Lebanese Ministry of Public Health, influenced by prior implementations within the Gulf Cooperation Council (GCC), represent a crucial area of focus. These updates necessitate continuous monitoring and adaptation to ensure regulatory compliance and facilitate the successful placement of pharmaceutical products within the Lebanese market. In conclusion, while sharing a foundation rooted in the JFDA, the regulatory environments of Lebanon and Syria possess unique characteristics requiring a tailored approach to pharmaceutical product registration.Let's take-off See you onboard
