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

posted by wienui  – Germany/Oman, 2022-07-07 22:48 (746 d 17:34 ago) – Posting: # 23114
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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

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