Ohlbe
★★★

France,
2020-02-28 14:23
(894 d 00:56 ago)

Posting: # 21189
Views: 2,702
 

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

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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
(893 d 22:38 ago)

@ Ohlbe
Posting: # 21190
Views: 1,803
 

 New Art. 31 referral: suspected data manipulation again

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

France,
2020-07-24 15:12
(747 d 01:06 ago)

@ Ohlbe
Posting: # 21787
Views: 1,141
 

 Referral concluded

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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
★★★
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Vienna, Austria,
2020-07-24 18:00
(746 d 22:18 ago)

@ Ohlbe
Posting: # 21788
Views: 1,124
 

 😡

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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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