ICH E6 Rev. 2 by EMA - I need help [GxP / QC / QA]

posted by BE-proff – 2015-08-26 01:24 (3945 d 20:23 ago) – Posting: # 15331
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Hi ElMaestro,

I have also some questions to this edition but on the other hand this GCP version is not final and thus can be changed :cool:

as for risks...if you see any risks and you can prove in writing that they are not signficant in your case I think it will be enough :-)
Paper will never describe all possible situations.

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