Bioequivalence and Bioavailability Forum • Speculations

Speculations [BE/BA News]

posted by ElMaestro – Denmark, 2014-12-07 21:20 (3865 d 21:47 ago) – Posting: # 14004
Views: 22,556

Hi Hötzi,

❝ Duno. Greed?

Greed is a cause, yes. I think some CROs know that vendor oversight is very relaxed among EU-based dossier developers and generic companies. The coverage is not very good. Only rarely do they in fact audit properly prior to studies and almost never afterwards. Much of the so-called audits are visit from business development people or other people who don't really look in depth at the QMS yet call it an audit still. I believe CROs know the game well. So in a sense I think GVK Bio were unlucky, they were detected against the odds. I wonder what else is out there.

—
Pass or fail!
ElMaestro

Complete thread:

Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51
  - Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
    - Bioequivalence in prime time TV news nobody 2014-12-05 16:56
      - Bioequivalence in prime time TV news Helmut 2014-12-05 17:24
    - Bioequivalence in prime time TV news nobody 2015-01-23 17:08
- If you know German… Helmut 2014-12-05 13:27
  - If you know German… nobody 2014-12-05 14:20
    - Monitoring CROs Helmut 2014-12-05 17:49
      - Monitoring CROs nobody 2014-12-05 18:02
        
        Ethics? Helmut 2014-12-05 22:54
        
        Ethics? nobody 2014-12-06 14:23
      - Monitoring CROs ElMaestro 2014-12-06 22:10
        
        Monitoring CROs Helmut 2014-12-07 14:08
        
        Monitoring CROs nobody 2014-12-12 10:51
        
        Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
- RCA ElMaestro 2014-12-07 01:06
  - Speculations Helmut 2014-12-07 14:41
    - Speculations nobody 2014-12-07 17:31
    - SpeculationsElMaestro 2014-12-07 20:20