|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/regulatory-affairs-cmc/
课程评论：没有评论
**课程名称：** 监管事务：CMC（化学、制造与控制） **课程概述：** 本课程全面介绍了CMC（化学、制造与控制）在产品申报文件中的作用，阐述了支持产品申请所需的CMC信息，识别需要进行备案的CMC变更，并深入讲解了支持上市申请及上市后提交（包括药品主文件DMFs和IMPD的CMC部分）所需的CMC信息。该课程是您进行资格认证和职业发展的最佳选择。 总的来说，尽管存在地域差异，但大多数卫生监管机构都期望临床试验申请以及CTD/eCTD申报文件中提供越来越多的信息和深入的技术知识。本课程将涵盖CMC信息的相关法规要求、发展历史、指导原则及实用技巧。 **主讲人：** D. Ladanovska（监管事务顾问，监管事务负责人） **旁白：** Liyonish（美国歌手、演员、演讲者） **完成课程后，您将能够：** * 识别支持临床研究和上市申请所需的CMC信息。 * 讨论在准备或更新CMC部分时应参考的ICH及各国/地区指导原则的作用。 * 识别需要向监管机构申报的CMC变更。 * 解释不同类型的上市后提交。 * 描述药品主文件（DMFs）的使用。 * 掌握IMPD质量部分的注意事项。 * 成为CMC主要指导原则方面的专家。 课程以平静的旁白为您展开，帮助您拓宽知识面，为未来的职业挑战和成功做好准备。让我们开始吧！
This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC changes that are required for amendments, and provides an understanding of the CMC information needed to support marketing applications and postapproval submissions, including the use of Drug Master Files (DMFs) and CMC for IMPD. The best choice for future certification and career promotion. In general, despite regional differences, most health authorities expect an increasing amount of information and a depth of technical knowledge to be provided in clinical trial applications, CTD/eCTD dossiers. Regulatory requirements for CMC information, history of CMC, guidance, and tips are provided within the scope of this course. Creator of this course - D. Ladanovska (RA Consultant, Head of RA)Speaker of this course - Liyonish (US singer, actress, speaker) Upon completion of this course, you will be able to:Identify the CMC information required for submissions to support clinical studies and marketing applications;Discuss the role of ICH and individual national/regional guidances that should be referenced when preparing or updating a CMC section;Identify CMC changes that require agency notification;Explain different types of postapproval submissions;Describe the use of Drug Master Files (DMFs);Use tips for the IMPD Quality part;Be an expert in the main CMC-guidances. With a calm invited narrator's voice in this course, be ready to expand your knowledge and be prepared for future career challenges and winnings. Let's go!
