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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-devices-registration-in-the-uk/
课程评论：没有评论
课程名称：英国MHRA监管事务硕士课程 课程概述：本课程旨在帮助学员深入掌握医疗器械在英国这一全球最大的市场中的注册过程。MHRA（药品和医疗器械监管局）是负责确保药品、医疗器械及输血用血液成分符合安全、有效和质量标准的英国监管机构。课程内容涵盖MHRA的法规要求及其在脱欧后独立运作的监管框架。学生将了解MHRA监管流程，包括产品注册、与其他地区（如爱尔兰）法规的比较，以及当前的市场准入路径。 学习内容： 1. MHRA产品注册流程的详细解析。 2. 各类监管途径的比较，如国家程序、国际认可程序以及创新许可与获取途径等。 3. MHRA药物警戒系统及黄卡计划的实际应用。 4. 全球药品监管的合作与协调，涉及FDA、EMA、WHO等机构。 5. 医疗器械在英国市场的特殊要求及申请流程，包括临时规定、分类、验证及特殊条件。 通过本课程，学员将能够更快地将产品推向市场，从而及时实现商业收益。此外，课程还将提供实际的表单、模板，以及如何准备提交文件的实用指导，确保学员能够与MHRA的提交渠道顺利对接。 结语：亲爱的制药行业未来专业人士，欢迎与我们共同踏上探索医疗器械注册英国市场的旅程！在这旅途中，您将掌握所有相关知识，并最终成功注册您的产品。期待在制药行业与您相见！
Master medical devices registration in the most important and biggest market ever in the world, the market of UK, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.The MHRA (Medicines and Healthcare Products Regulatory Agency) is the UK's regulatory body responsible for ensuring that medicines, medical devices, and blood components for transfusion meet applicable safety, efficacy, and quality standards. It operates under the Department of Health and Social Care (DHSC) and plays a key role in regulating pharmaceuticals post-Brexit.What will you learn?Product registration with MHRA Master Regulatory Affairs processes of MHRA The best regulatory pathway for the best productHandling and matching MHRA regulatory pathways Comparing the UK, to Britain, to Ireland regulationsWhis is the leader of the Great Britain region when it comes to regulationsWhat Ireland follows, and does not follow with MHRA MHRA before and after Brexit In this course we will be introduced to the details of MHRA regulations considering Brexit & UK Regulatory FrameworkSince Brexit, the UK has followed its regulatory framework, separate from the European Medicines Agency (EMA).Great Britain (England, Scotland, Wales) follows MHRA rules.Northern Ireland still follows EMA regulations under the Northern Ireland Protocol.We will master MHRA Regulatory PathwaysNational Procedure (NP) - Full UK approval process for new medicines.International Recognition Procedure (IRP) - Fast-track approval based on FDA, EMA, or other major agencies' decisions.Innovative Licensing and Access Pathway (ILAP) - Accelerated pathway for innovative medicines (e.g., rare diseases, advanced therapies).Rolling Review - Early engagement with MHRA for urgent treatments.We will get introduced to MHRA Pharmacovigilance system: The Yellow Card SchemeYellow Card Scheme allows reporting of adverse drug reactions (ADRs), medical device failures, and counterfeit drugs.Monitored by MHRA and the Commission on Human Medicines (CHM). To have a global view of MHRA Collaboration & Global RoleWorks with FDA (US), EMA (EU), WHO, and ICH for regulatory harmonization.Active in Good Pharmacovigilance Practices (GVP) and International Coalition of Medicines Regulatory Authorities (ICMRA).So, from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, with lots of innovations and different versions of the same medical device could be played within the potential market of the UK.Dear pharma industry future professionals, let us start our interesting journey toward medical device registration in the UK, we will travel together to the UK, meet the health authority there "MHRA", and explore its requirements for registration, renewal, and variations, let us place our products there.In this course, we will cover all topics related to medical devices in the UK, starting from the requirements, interim regulations, classification, verification, and special conditions.Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, of the medical, and interact with the actual MHRA gateway for the submission. and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for UK market importation. And finally, congratulations to you for mastering medical device registration in the UK market and see you soon in the pharma industry my dear colleagues. Let's go
