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所在平台: Udemy |
课程主页: https://www.udemy.com/course/e-learning-of-regulatory-affairs-of-medical-device/
课程评论：没有评论
**课程名称：** 医疗器械法规事务电子学习 **课程概述：** 本课程旨在为医疗技术领域的职业人士（无论处于何种职业阶段）提供法规情报。您将学习从欧盟MDR到美国FDA、中国NMPA等地的注册路径。 **目标受众：** * **学生和失业人群：** 学习中国注册的基本知识。 * **非医疗技术专业人士：** 获得中国市场准入的概览和策略，对医疗撰稿人等有益。 * **非法规事务专业人士：** 适合职业转型。 * **法规事务专业人士：** 无论是否有注册经验，都能提高注册效率，是法规事务团队的理想强化培训。 **课程模块：** * 中国准入 * 中国注册 * 中国上市后及质量管理 * 全球市场 * 法规事务软技能 * FDA及加拿大 * CE认证 * 新加坡、马来西亚及越南 * 台湾 **课程设置：** 每个模块包含脚本、视频、测试和案例研究。专业模块提供与精选法规专家的面对面辅导。 **课程起始与时长：** * **开始时间：** 任何时间均可参与。 * **时长：** 1年。 **如何开始：** 与培训师进行启动会议，并预约培训。 **课程结束：** * **专业用户：** 完成测试、免费辅导时数和获得证书。 * **电子学习证明：** 成功通过每个模块的测试和高质量的作业后，将颁发证书。
We want to share regulatory intelligence with you indepedent in which career level you are staying at medtech. You will learn registration pathway from EU, MDR to US, FDA and CN NMPA etc...Learning audienceStudent and unemployed:Basic knowledge for Chinese registrationNon Medtech personal:Gain overview and tactic of Chinese market entry, useful for publication (medical writers)Non Regulatory personal:Perfect for career changerRegulatory professionals:Either with or without experience of registration, improve registration efficiency, ideal as boot camp for RA groupOn website of easychinapprov, you can select any session what you wish to learnSession: Chinese accessSession: Registration in ChinaSession: Chinese Post market and quality managementSession: Global marketsSession: Regulatory Affairs Soft SkillsSession: FDA and CanadaSession: CE cerfiticationSession: Singapore, Malaysia and VietnamSession: TaiwanEach session is made of script, video, test and case study. In professional modul you can have face to face coach with our best chosen regulatory expert.Start: Participation possible any time.Duration: 1 yearHow to start: Kick off meeting with trainer, book trainingEnd of E-Learning: for professional user there is test, free supervision hours and certificateProof of E-learningA certificate will be issued after successful test for each session and qualitative homework.
