Ohlbe
★★★

France,
2020-02-28 15:23
(1490 d 22:22 ago)

Posting: # 21189
Views: 3,740
 

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

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
(1490 d 20:05 ago)

@ Ohlbe
Posting: # 21190
Views: 2,638
 

 New Art. 31 referral: suspected data manipulation again

Panexcell? Really? Good laugh...

Kindest regards, nobody
Ohlbe
★★★

France,
2020-07-24 17:12
(1343 d 21:33 ago)

@ Ohlbe
Posting: # 21787
Views: 2,009
 

 Referral concluded

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
(1343 d 18:45 ago)

@ Ohlbe
Posting: # 21788
Views: 1,945
 

 💯

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
22,957 posts in 4,819 threads, 1,636 registered users;
118 visitors (0 registered, 118 guests [including 4 identified bots]).
Forum time: 13:46 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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