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

posted by Helmut Homepage – Vienna, Austria, 2022-05-24 18:35 (673 d 22:18 ago) – Posting: # 23015
Views: 3,739

Dear Ohlbe,

❝ 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.


Good point!

❝ 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.


I was once hired by the potential buyer of a dossier to assess it. I asked for the language. Spanish. Told them that my knowledge goes hardly beyond ¡Hola! ¿Qué hay? Paella, Rioja, cerveza. Answer: Fair enough, that’s fine. OK, business class flight to Barcelona, locked (!) for hours in a room with twenty binders. Funny.

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

❝ Or just incompetent ?


Another good point. However, it’s not rocket since, right?

❝ 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 ?


Possible. Shyte.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
75 visitors (0 registered, 75 guests [including 10 identified bots]).
Forum time: 15:54 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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