Ohlbe
★★★

France,
2020-02-28 15:23
(1490 d 06:53 ago)

Posting: # 21189
Views: 3,731
 

 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 04:36 ago)

@ Ohlbe
Posting: # 21190
Views: 2,632
 

 New Art. 31 referral: suspected data manipulation again

Panexcell? Really? Good laugh...

Kindest regards, nobody
Ohlbe
★★★

France,
2020-07-24 17:12
(1343 d 06:03 ago)

@ Ohlbe
Posting: # 21787
Views: 2,002
 

 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 03:15 ago)

@ Ohlbe
Posting: # 21788
Views: 1,938
 

 💯

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;
83 visitors (0 registered, 83 guests [including 13 identified bots]).
Forum time: 22:16 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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