Bioequivalence and Bioavailability Forum • Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph

Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2022-07-07 22:48 (517 d 11:20 ago) – Posting: # 23114
Views: 1,919

Dear Ohlbe ,Divyen & all,

Yes, the pot is full and this calls us (Regulatory + Industry) to unite to fight those types of frauds, otherwise, the patient will lose complete confidence in the drugs, especially the Generic drugs.
But let us return to the main topic, should the regulatory authorities refuse the submission and acceptance of BE studies that have been performed in a CRO belonging to the sponsor? are there any references? or are there other opinions other than that?

—
Cheers,
Osama

Complete thread:

Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-07 10:37 [Regulatives / Guidelines]
- Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Ohlbe 2022-07-07 10:55
  - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph dshah 2022-07-07 18:52
    - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Phwienui 2022-07-07 20:48
      - Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph dshah 2022-07-08 10:23
- Conflicts of interest (COI) ElMaestro 2022-07-08 13:18
  - Off topic Helmut 2022-07-08 16:29
    - Off topic ElMaestro 2022-07-08 16:54
      - Off topic Helmut 2022-07-08 20:41
        
        CRO belong to the pharmaceutical Company (CRO b2Ph wienui 2022-07-08 22:18
        
        CRO belong to the pharmaceutical Company (CRO b2Ph ElMaestro 2022-07-09 08:51
        
        CRO subsidiary of pharmaceutical company Helmut 2022-07-09 19:21