Ohlbe
★★★

France,
2020-02-28 14:23
(818 d 23:26 ago)

Posting: # 21189
Views: 2,599
 

 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 16:40
(818 d 21:09 ago)

@ Ohlbe
Posting: # 21190
Views: 1,724
 

 New Art. 31 referral: suspected data manipulation again

Panexcell? Really? Good laugh...

Kindest regards, nobody
Ohlbe
★★★

France,
2020-07-24 15:12
(671 d 23:37 ago)

@ Ohlbe
Posting: # 21787
Views: 1,060
 

 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 18:00
(671 d 20:49 ago)

@ Ohlbe
Posting: # 21788
Views: 1,044
 

 😡

Dear Ohlbe,

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

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