2020年2月11日 · The document provides an overview of MedDRA, including: - MedDRA was developed under ICH to facilitate exchange of safety information. Its maintenance is overseen by an ICH committee. - It defines MedDRA as a medical terminology used for regulatory processes from pre- to post-marketing.

2018年10月19日 · MedDRA is a standardized medical terminology used in the pharmaceutical industry and regulatory bodies for coding adverse event reports. It contains over 60,000 terms organized into a hierarchical structure with 5 levels across 26 system organ classes.

2013年11月27日 · This document provides an introduction and overview of MedDRA, the medical terminology used for medical coding in the pharmaceutical industry. It discusses the history and development of MedDRA, which originated from the need for a single, standardized terminology to classify medical information for regulatory purposes.

2018年6月8日 · Introduction to MedDRA MedDRA介绍课件.ppt,copyright Huntley Consulting LLC 2004 Introduction to MedDRA MedDRA介绍 Kathryn Huntley Huntley Consulting, LLC 2004年11月 Ter

2022年10月11日 · 制定《药品上市许可持有人MedDRA编码指南》 遵循MSSO《MedDRA术语选择：考虑要点》基础上，结合我国实际情况制定的补充指南 积极推进M1转化实施 目的：指导药品上市许可持有人在药品上市后不 良反应报告相关工作中使用MedDRA编码相关医 学术语，提高持 …

12 MedDRA DefinitionMedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry.

2016年11月2日 · 入 门 指南 MedDRA 18.1 版 MSSO-DI-6003-18.1.0 2015 年 9 月

2018年3月21日 · Introduction to MedDRA MedDRA介绍;Terminology requirements 对术语的要求;Development Philosophy 编写原则; ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 人用药品注册技术规范国际协调会 Created to make recommendations on ways to achieve ...

6 MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. Core slide

5 MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. Core slide