Ohlbe
★★★

France,
2020-02-28 13:23
(417 d 06:39 ago)

Posting: # 21189
Views: 2,028
 

 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 15:40
(417 d 04:22 ago)

@ Ohlbe
Posting: # 21190
Views: 1,248
 

 New Art. 31 referral: suspected data manipulation again

Panexcell? Really? Good laugh...

Kindest regards, nobody
Ohlbe
★★★

France,
2020-07-24 13:12
(270 d 06:49 ago)

@ Ohlbe
Posting: # 21787
Views: 570
 

 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 16:00
(270 d 04:01 ago)

@ Ohlbe
Posting: # 21788
Views: 562
 

 😡

Dear Ohlbe,

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

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Helmut Schütz
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