促进GMP的实施:开发面向国际受众的培训材料。

Kazushige Morimoto, Judith Curry, Sabine Kopp, Lembit Rägo, Andre van Zyl, Eshetu Wondemagegnehu, Jonathan Quick, Yasuhiro Suzuki
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引用次数: 3

摘要

本文概述了编制题为“卫生组织GMP基本培训模块”的光盘培训包的情况,目的是支持开设培训课程,特别针对检查药品生产设施的政府合规官员。该材料是与外部专家小组、世卫组织区域和地方办事处以及参与国的药物管理当局合作,历时三年编写的。来自47个国家的约240名与会者参加了促进发展和评价进程的9个培训讲习班和课程。迄今为止,已分发了5 800多份光盘。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Promoting GMP implementation: developing training materials for the international audience.

This paper outlines the development of a CD-ROM training package entitled: The WHO Basic Training Modules on GMP, intended to support the creation of training courses aimed particularly at government compliance officials who inspect pharmaceutical manufacturing facilities. The material was created over a three-year period in collaboration with a team of external experts, WHO regional and local offices, and Drug Regulatory Authorities of participating countries. The nine training workshops and courses that contributed to the development and evaluation processes were attended by approximately 240 participants from 47 countries. To date over 5,800 copies of the CD-ROM have been distributed.

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