Helmut
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Vienna, Austria,
2009-08-05 18:03
(6159 d 13:21 ago)

Posting: # 4010
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 EMEA/FDA: GCP inspection activities [GxP / QC / QA]

Dear all!

EMEA and the FDA have agreed to launch a joint initiative to collaborate on international Good Clinical Practice (GCP) inspection activities.
For details see the news-section.

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skumarve
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2009-08-18 08:19
(6146 d 23:06 ago)

@ Helmut
Posting: # 4058
Views: 5,222
 

 EMEA/FDA: GCP inspection activities

Dear HS,

Thanks for information. In this regard we would like to know whether there is any outcome related to submission of same ba/be study to both FDA & EU countries.

Regards,

SKUMAVE


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
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