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所在平台: Udemy |
课程主页: https://www.udemy.com/course/ectd-ctd-preparation-submission-course/
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**课程名称：** eCTD & CTD 准备与提交课程 2025 **课程概述：** 本课程深入讲解了电子通用技术文件 (eCTD) 规范，该规范旨在促进药品注册申报资料的全球电子提交、审评和生命周期管理。课程强调 eCTD 的动态性，涵盖了变异（variations）、续期（renewals）和修正（amendments）等信息，使其超越了静态文件的范畴，可在产品整个生命周期中进行更新。 **课程内容亮点：** * **eCTD 规范详解：** 详细介绍 eCTD 规范、处理区域性申报差异的方法，并提供 eCTD 申报资料创建的指导。 * **实操培训：** 提供实际操作培训，帮助学员掌握 eCTD 申报资料的编译和填写。 * **从纸质到电子的转变：** 讲解如何从纸质提交方式过渡到 eCTD 电子提交。 * **生命周期管理：** 介绍 eCTD 的生命周期管理。 * **eCTD 软件应用：** 重点介绍用于编译和验证的 eCTD 软件。 * **行业价值：** 对于监管事务、质量控制/保证、文件部门的专业人士以及寻求在这些领域发展机会的科学毕业生尤为重要。 **学习成果：** * 掌握 CTD 和 eCTD 的基本知识。 * 协助编译和填写 eCTD 申报资料。 * 识别欧盟和美国的 eCTD 申报要求。 * 能够完成从纸质提交到 eCTD 提交的转变。 * 掌握 eCTD 申报资料的审阅。 **课程结构：** * 引言与 CTD 概述 * CTD 基础（模块 1-5） * eCTD 基础与详情 * eCTD 准备的最佳实践 * 使用 eCTD 格式进行申报 * eCTD 的生命周期管理 * eCTD 编译与验证软件 **适合人群：** * 质量控制/质量保证经理及员工 * 文件部门人员 * 负责 CTD/DMF 准备与提交的法规事务部门人员 * 参与文件工作的研究化学家、质量控制化学家、 CRO 机构人员 * 具备 CTD 知识的药学毕业生 * 寻求在法规事务领域就业机会的任何科学毕业生 **教学方法：** * 提供课程和学习材料 * 提供 eCTD 实践操作培训 * 允许学员在课程期间向讲师提问 **认证价值与就业机会：** 获得认证后，可进入以下职位： * 法规事务专员 * 法规事务助理 * 法规事务主管/总监 * 医学信息助理 * 药检员/药品监管官员 * 药物安全专家/法规食品安全科学家 * 质量运营/质量控制/质量保证 **资格要求：** 拥有生命科学学位，且具备法规事务相关经验或知识。 **重要提示：** 课程提供终身访问权限，学员可根据个人时间安排学习。相比私立机构数千元或 70 美元的费用，本课程性价比极高。
The eCTD specification has been developed to facilitate the Global electronic Submission, Review and Lifecycle management of medicinal product dossiers for regulatory applications. *Complete the course as per your free time as life time access is available.If you are paying more than 5k INR or $70 for private institute/academy then you are in loss. Please compare the course description and amount you are paying for such course.It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. If you are paying more than 5k INR or $15 for private institute/academy then you are in loss. Please compare the course description and amount you are paying for such course.The module provides a training and reference tool that will be of particular value to those new to the use of the format.This online course details the Electronic Common Technical Document specification, provides guidance on the creation of the submission of an eCTD, and discusses the approach to regional differences in dossiers. This relatively fresh aspect of submissions will undergo significant and rapid changes as specifications are refined and modified further. This class is a superb training tool and reference and can be of assistance to anyone involved with electronic submissions and in navigating these changing requirements.Once all course requirements have been satisfied, a certificate of completion is immediately available. Learning OutcomeBasic Understanding of CTD & eCTDAssisting in Compiling & filling and eCTD ApplicationIdentifying EU & US Requirement for eCTDTransiting from Paper based Submission to eCTD SubmissionReview eCTD ApplicationCourse StructureIntroduction & Overview of CTDCTD Fundamentals ( Module 1 - 5)eCTD Fundamentals & DetailsBest Practice in Preparing eCTDSubmission using eCTD FormatLife Cycle Management for eCTDeCTD Software for Compilation & ValidationWho will Benefit ???QC/QA Managers & StaffDocumentation DepartmentRegulatory Affairs Department - Responsible for CTD /DMF Preparation & SubmissionResearch Chemist, Quality Control Chemist, CRO's involved in DocumentationPharmacy Graduates with knowledge of CTDAny science graduates who are seeking job opportunities in Regulatory AffairsTeaching MethodologyParticipants will be provided with course & study materialPractical Training will be provided on eCTD.Paritcipants can ask their query/questions to the instructor during the course.Benefits of Getting Certified then job opportunities asRegulatory Affairs AssociatesRegulatory Affairs AssistanceRegulatory Affairs Head/ DirectorMedical Information AssociatesDrug Inspector/Drug ControlleDrug Safety Specialist/ Regulatory Food Safety ScientistQuality Operations/Quality Control/Quality AssuranceEligibilityLife Science Graduates with Experience or Knowledge of Regulatory Affairs
