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Dr_Dan ★★ Germany, 2016-12-20 10:33 (3017 d 06:43 ago) Posting: # 16862 Views: 7,631 |
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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 |
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Ohlbe ★★★ France, 2016-12-20 11:04 (3017 d 06:13 ago) @ Dr_Dan Posting: # 16863 Views: 6,637 |
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Dear Dan, ❝ Does anybody have an idea which were the findings that lead to this decision? Some information in the referral notification. — Regards Ohlbe |
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nobody nothing 2016-12-20 11:15 (3017 d 06:02 ago) @ Ohlbe Posting: # 16864 Views: 6,642 |
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...and some here http://www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2015/07/WC500190088.pdf ...starting page 15/39... — Kindest regards, nobody |
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Dr_Dan ★★ Germany, 2016-12-20 12:05 (3017 d 05:11 ago) @ nobody Posting: # 16865 Views: 6,517 |
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- 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 |
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nobody nothing 2016-12-20 12:19 (3017 d 04:58 ago) @ Dr_Dan Posting: # 16866 Views: 6,556 |
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Are my posts on your IGNORE list?  — Kindest regards, nobody |
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Ohlbe ★★★ France, 2017-03-24 15:30 (2923 d 01:47 ago) @ Dr_Dan Posting: # 17182 Views: 5,586 |
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— Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2017-03-24 17:19 (2922 d 23:58 ago) @ Ohlbe Posting: # 17183 Views: 5,554 |
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Dear Ohlbe, THX! The list of list of medicines recommended for suspension runs over an impressive 32 pages… — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz