MHRA数据完整性指南-2018中英文版

冷雪清风 · 发表于 2018-3-27 10:08:09

真是非常棒

日出沧海 · 发表于 2018-3-28 08:11:53

谢谢

hongyu · 发表于 2018-3-28 09:16:26

谢谢谢谢

圆的紫叶 · 发表于 2018-3-28 10:22:57

谢谢

冷雪清风 · 发表于 2018-3-30 09:13:08

看来还是要每天逛逛蒲公英，及时掌握信息

rlz0203 · 发表于 2018-3-31 13:33:53

牛，谢谢分享，下载进行学习

humz · 发表于 2018-4-4 08:25:58

非常感谢，真是及时雨~

tyrxxl · 发表于 2018-4-10 14:08:30

非常感谢，学习学习

情系美西南 · 发表于 2018-4-18 12:54:09

thanks for sharing !!

laohan521 · 发表于 2018-4-22 20:54:35

级别不够不能下载！！！

Summer天 · 发表于 2018-4-24 16:28:59

这个就厉害了

luislu · 发表于 2018-4-25 10:17:59

2018.。。那么新么。谢谢分享。学习啦

预知子 · 发表于 2018-4-25 10:26:37

laohan521 发表于 2018-4-22 20:54
级别不够不能下载！！！

没设权限啊

chaishiying · 发表于 2018-4-26 08:53:46

以为没有刚准备自己费尽翻译谢谢分享

sp0917 · 发表于 2018-4-27 14:02:33

楼主辛苦，谢谢分享

罗伊鲱 · 发表于 2018-7-4 09:04:06

本帖最后由 roadman 于 2018-7-4 09:15 编辑

April 2, 2018

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The MHRA Inspectorate blog says that the health authority received over 1300 comments during the consultation process. The revision was a coordinated effort among the GCP, GDP, GLP, GMP and GPvP inspection groups reflecting a broad source of input. MHRA specifically, however, excluded devices from the scope of this guidance. Regarding alignment with guidance from other health authorities, MHRA states: “The GXP data integrity guidance has a high degree of alignment with documents published by other regulators such as PIC/S, WHO, OECD (guidance and advisory documents on GLP) and EMA. It is designed to facilitate compliance through education, whilst clarifying the MHRA’s position on data integrity and the minimum expectation to achieve compliance.” READ MORE…

轰天乌驹 · 发表于 2018-7-5 11:00:22

自己看了了半天，好多没看明白，看看大咖的成果学习一下

y00010w · 发表于 2018-7-7 16:56:23

谢谢分享资料。。

lijnwi · 发表于 2018-7-10 16:22:46

冷血无情发表于 2018-3-14 07:59
借楼感谢朱版主~

谢谢分享，学习一下！

璇璇爸 · 发表于 2018-7-14 16:34:25

学习学习

[欧盟药事] MHRA数据完整性指南-2018中英文版

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