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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-devices-registration-in-europe/
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课程名称：欧洲EMA监管事务硕士课程 课程概述：本课程旨在教授学员如何在全球最大的市场——欧洲市场，掌握医疗器械的注册流程。该市场对于任何制药或医疗保健公司来说都是至关重要的，制药行业的专业人士深知其重要性及预期收益。负责评估、批准及监管欧盟内药品的机构是欧洲药品管理局（EMA），其主要职责包括药品的评估与批准，确保所售药品的高质量、安全性与有效性。我们将探讨EMA的综合审批过程、科学委员会对新药的评估、紧急医疗需求的快速审批流程及不良反应的收集与分析系统EudraVigilance等。 在课程中，您将学习到： - EMA门户的使用 - 欧洲医疗器械的注册与分类 - 欧洲的法规协调 - 各国更新及应对情况 - MHRA、TGA及FDA的相关情况与EMA的响应 - 产品进口、续期及变更 - EUDAMED数据库与EUDRAVIGILANCE系统 - 转向MDR的知识 课程内容会涵盖与医疗器械相关的所有主题，从要求、临时规定、分类、验证到特殊条件。我们将介绍EMA的委员会，如人用药品委员会（CHMP）、药物安全监测委员会（PRAC）、孤儿药物委员会（COMP）和先进治疗委员会（CAT），并探讨EMA的法规路径选择，包括集中程序、去中心化程序、互认程序及国家程序。 此外，我们将深入了解实际的表单和模板，确保提交文档的准备与验证，同时与MHRA提交门户进行互动。课程的最后，您将学习到与欧洲市场进口相关的海关清关、追踪/追踪系统、条形码及2D矩阵等知识。 祝贺您成功掌握医疗器械在欧洲市场的注册流程，期待在制药行业再见，亲爱的同事们！
Master medical devices registration in the most important and biggest market ever in the world, the European market, 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 regulatory agency in charge of assessing, approving, and overseeing medications inside the European Union (EU) is the European Medicines Agency (EMA). It guarantees the high quality, safety, and efficacy of medications sold in the EU. The EMA's primary duties include medicine evaluation and approval. centralized process for approving marketing in every EU nation. Scientific committees evaluate new medications. expedited permission (e.g., conditional approvals, fast assessments) for urgent medical requirements. The EudraVigilance system is used for the collection and assessment of adverse drug reactions (ADRs). RMPs (risk management plans) for recently authorized medications. Guidelines & Scientific Research. uses the EU Clinical Trials Information System (CTIS) and the Clinical Trials Regulation (CTR) to oversee clinical trials. Examining and Complying ensures adherence to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP) by collaborating with national authorities.What will you learn?Get introduced to EMA Master EMA portalMaster Medical Devices Registration in EuropeMaster Medical Devices Classification in Europe Master regulatory harmonization across EuropeKeep an eye on the updates and each country's responseMHRA, TGA, and FDA situation and response from EMA Master products Importation, renewal, and variationEUDAMED database EUDRAVIGILANCE Shifting to MDR In this course, we will cover all topics related to medical devices in Europe, starting from the requirements, interim regulations, classification, verification, and special conditions. we will get introduced to EMA committees:Committee for Medicinal Products for Human Use (CHMP) - Reviews and approves new medicines.Pharmacovigilance Risk Assessment Committee (PRAC) - Monitors drug safety.Committee for Orphan Medicinal Products (COMP) - Manages rare disease treatments.Committee for Advanced Therapies (CAT) - Assesses gene and cell therapies.Will Explore together EMA regulatory pathways and how to choose the best one suitable for which productCentralized Procedure (mandatory for biotech, orphan, and advanced therapies)Decentralized Procedure (for medicines not covered by the centralized route)Mutual Recognition Procedure (MRP) (approval in one EU country extended to others)National Procedure (only applicable in a single EU member state)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 the European market importation. And finally, congratulations to you for mastering medical device registration in the European market and see you soon in the pharma industry my dear colleagues.
