Blind monitors or greedy sponsors? [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-24 16:21 (892 d 18:31 ago) – Posting: # 23014
Views: 5,791

Dear Helmut,

❝ also interesting the list of medicines concerned by the procedure. You can read it ‘backwards’, i.e., look at the sponsors.


Well, marketing authorisation holders / applicants were not necessarily the sponsor of the study. Some of them just bought the dossier off the shelf, before or after the marketing authorisation was granted. Due diligence: generally, nil, especially if the marketing authorisation was already granted. EMA organised a workshop with representatives of the generic drug industry some years ago, after the first referrals of this type. Nothing came out of it. Industry's position: "we can't audit the study when we buy the dossier coz' we were not the sponsor". It went nowhere.

❝ Given that, were monitors of the other sponsors :blind: or just greedy?


Or just incompetent ? Or were some of the sponsors perfectly aware of the scam, and willing to use such CROs precisely because they were sure their study would pass ?

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,279 posts in 4,889 threads, 1,657 registered users;
69 visitors (0 registered, 69 guests [including 10 identified bots]).
Forum time: 09:52 CET (Europe/Vienna)

Pharmacokinetics: one of the magic arts of divination
whereby needles are stuck into dummies in an attempt
to predict profits.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5