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所在平台: Udemy |
课程主页: https://www.udemy.com/course/master-medical-devices-registration-in-canada/
课程评论：没有评论
课程名称：掌握加拿大医疗器械注册 概述：本课程将帮助您掌握医疗器械注册的关键知识，聚焦于加拿大这一全球最大市场的重要性。了解加拿大市场对于药品和医疗保健公司来说的重大影响，以及期待带来的巨大收入是本课程的核心内容。加拿大卫生部（Health Canada）是负责审查、批准和监督药品、生物制品、医疗器械及其他健康相关产品的监管机构，确保在加拿大发售的药物安全、有效且高质量。 您将学习到的内容包括： - 了解加拿大卫生部和其门户网站 - 加拿大医疗器械法规 - 加拿大医疗器械分类 - 申请流程、续期及变更 - 最新动态 课程将介绍加拿大卫生部的监管路径，包括： - 新药申请（NDS）- 针对新药产品的要求 - 简化新药申请（ANDS）- 用于仿制药 - 临床试验申请（CTA）- 启动人体试验前的必要申请 - 生物制药及放射性药物申请（BRD/NDS）- 针对生物制剂 - 自然健康产品（NHP）申请- 针对维生素、补充剂和草药 此外，课程还将介绍加拿大的上市后监管职责，包括： - 加拿大警示计划（Canada Vigilance Program）- 收集不良药物反应报告 - MedEffect Canada- 提供药物召回和安全问题的公众警报 卫生部与全球监管机构如美国FDA、EMA、WHO紧密合作，朝着全球统一化趋势迈进。从商业角度看，您能更快将产品推向市场，迅速获得收益。医疗器械领域相对于药品而言高度动态和创新，众多创新和不同版本的医疗器械将在加拿大市场中占有一席之地。 亲爱的制药行业未来专业人士们，让我们开始这段有趣的旅程，学习在加拿大进行医疗器械注册的所有内容，包括要求、临时法规、分类、验证、特殊条件等。 最后，祝贺您成功掌握加拿大市场医疗器械注册的知识，期待在制药行业中与您相见！让我们启程前往加拿大吧！
Master medical devices registration in the most important and biggest market ever in the world, the market of Canada, 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.Health Canada is the regulatory authority responsible for reviewing, approving, and monitoring pharmaceuticals, biologics, medical devices, and other health-related products in Canada. It ensures that drugs available in Canada are safe, effective, and of high quality.What will you learn?Get introduced to Health Canada Health Canada portal Medical Devices Regulations Canada Medical Devices Classification Canada Application process Renewals/ variations The updates In this course, we will be introduced to Health Canada's Regulatory Pathways: New Drug Submission (NDS) - Required for new pharmaceutical products.Abbreviated New Drug Submission (ANDS) - Used for generic drugs.Clinical Trial Application (CTA) - Required before starting human trials.Biologic and Radiopharmaceutical Drug Submission (BRD/NDS) - For biologics.Natural Health Product (NHP) Submission - For vitamins, supplements, and herbal medicines. Health Canada Post-Marketing Surveillance Responsibilities:Canada Vigilance Program - Collects adverse drug reaction reports.MedEffect Canada - Provides public alerts on drug recalls and safety issues.Health Canada is not alone in the global regulatory world; it has close collaboration with the U.S. FDA, EMA, and WHO in addition to being part of the ICH towards the global trend of harmonization. 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 Canada.Dear pharma industry future professionals, let us start our interesting journey toward medical device registration in the states, we will travel together to the States, meet the health authority there "HC", and explore its requirements for registration, renewal, and variations, let us get our "HC" approval and place our products there.In this course, we will cover all topics related to medical devices in Canada, starting from the requirements, interim regulations, classification, verification, special conditions, and weavingsAnd finally, congratulations to you for mastering medical device registration in the Canadian market and see you soon in the pharma industry my dear colleagues.Let's take off to Canada Let's go
