Dr_Dan
★★  

Germany,
2016-12-20 10:33
(2655 d 10:45 ago)

Posting: # 16862
Views: 6,612
 

 Start of referral: Micro Therapeutics Research Labs, India [GxP / QC / QA]

Dear all
The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union.
Does anybody have an idea which were the findings that lead to this decision?


Edit: Category changed. [Helmut]

Kind regards and have a nice day
Dr_Dan
Ohlbe
★★★

France,
2016-12-20 11:04
(2655 d 10:15 ago)

@ Dr_Dan
Posting: # 16863
Views: 5,821
 

 Start of referral: Micro Therapeutics Research Labs, India

Dear Dan,

❝ Does anybody have an idea which were the findings that lead to this decision?


Some information in the referral notification.

Regards
Ohlbe
nobody
nothing

2016-12-20 11:15
(2655 d 10:04 ago)

@ Ohlbe
Posting: # 16864
Views: 5,825
 

 Start of referral: Micro Therapeutics Research Labs, India


Kindest regards, nobody
Dr_Dan
★★  

Germany,
2016-12-20 12:05
(2655 d 09:14 ago)

@ nobody
Posting: # 16865
Views: 5,704
 

 Start of referral: Micro Therapeutics Research Labs, India

- ECG recordings showed inconsistencies (intentional misinterpretation)
- Generating source data retrospectively
- Documentation of incorrect information
- Overwriting and changing raw data without ensuring the readability of the initial entry
- Implausible changes without a sound justification
- IMP shipped before approval
...

O.k., the CRO worked at least in a slipshod way, but are they really that stupid, lazy or untrained or are there other reasons that can not be proven but which forced EMA to look for findings (or to interprete observations in such a way) as mentioned above, which -honestly- will more or less appear in each study if you only search sufficiently.

The issue with GVK layed in bioanalysis and the referral was due to ECG recordings and similars....

Kind regards and have a nice day
Dr_Dan
nobody
nothing

2016-12-20 12:19
(2655 d 09:00 ago)

@ Dr_Dan
Posting: # 16866
Views: 5,722
 

 Start of referral: Micro Therapeutics Research Labs, India

Are my posts on your IGNORE list? ;-)

Kindest regards, nobody
Ohlbe
★★★

France,
2017-03-24 15:30
(2561 d 05:49 ago)

@ Dr_Dan
Posting: # 17182
Views: 4,775
 

 CHMP opinion

Dear all,

The opinion of the CHMP has just been made public.

Regards
Ohlbe
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2017-03-24 17:19
(2561 d 04:00 ago)

@ Ohlbe
Posting: # 17183
Views: 4,711
 

 Oops!

Dear Ohlbe,

THX! The list of list of medicines recommended for suspension runs over an impressive 32 pages…

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