Ohlbe
★★★

France,
2020-02-28 15:23
(1873 d 17:00 ago)

Posting: # 21189
Views: 5,203
 

 New Art. 31 referral: suspected data manipulation again [GxP / QC / QA]

Post reply
Dear all,

A new Article 31 referral has been announced on the EMA web site. It looks like another CRO has been caught manipulating data to make a failing study pass. More details in the referral notification.
—
Regards
Ohlbe
 
nobody
nothing

2020-02-28 17:40
(1873 d 14:43 ago)

@ Ohlbe
Posting: # 21190
Views: 3,818
 

 New Art. 31 referral: suspected data manipulation again

Post reply
Panexcell? Really? Good laugh...
—
Kindest regards, nobody
 
Ohlbe
★★★

France,
2020-07-24 17:12
(1726 d 16:10 ago)

@ Ohlbe
Posting: # 21787
Views: 3,259
 

 Referral concluded

Post reply
Dear all,

The outcome of the referral was published today: all affected marketing authorisations will be suspended, ongoing applications will be rejected.
—
Regards
Ohlbe
 
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-07-24 20:00
(1726 d 13:22 ago)

@ Ohlbe
Posting: # 21788
Views: 3,122
 

 💯

Post reply
Dear Ohlbe,

splendid! A never-ending scavenger hunt. Of course, the October 2019 inspection is not listed there.

[image]

—
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
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,709 registered users;
37 visitors (0 registered, 37 guests [including 9 identified bots]).
Forum time: 09:23 CEST (Europe/Vienna)

A Camel is a Horse designed by committee.    Anonymous

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