Bioequivalence and Bioavailability Forum • Blind monitors or greedy sponsors?

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

posted by Helmut – Vienna, Austria, 2022-05-24 18:35 (701 d 19:00 ago) – Posting: # 23015
Views: 3,965

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 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!
Helmut Schütz

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Complete thread:

Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA]
- Another two... ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more info Ohlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors?Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selection Ohlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11