Helmut
★★★
avatar
Homepage
Vienna, Austria,
2009-08-05 18:03
(6156 d 05:57 ago)

Posting: # 4010
Views: 6,716
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
skumarve
●    

2009-08-18 08:19
(6143 d 15:42 ago)

@ Helmut
Posting: # 4058
Views: 5,215
 

 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]
UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
113 visitors (0 registered, 113 guests [including 21 identified bots]).
Forum time: 00:01 CEST (Europe/Vienna)

To propose that poor design can be corrected by subtle analysis techniques
is contrary to good scientific thinking.    Stuart J. Pocock

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5