Bonus questions [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2019-01-17 18:25 (1097 d 14:56 ago) – Posting: # 19782
Views: 3,501

Bonus questions:

5. The link above makes references to the PIC/S guidances, specifically the PI011-3 one which makes reference to GAMP.
GAMP, in turn, is pay per view, so...

5a: Does this mean GAMP principles are enforced for inspectors?
If yes:
5b: Does that imply sponsors need to observe principles from GAMP for clinical trial software?
If yes:
5c: When I was a regulator I thought any and all principles that regulators want sponsors or stakeholders to follow is and will be accessible free of charge. I thought this was one of the noble aspects associated with the term transparency which was in almost every other sentence in documents published by agencies. I don't have a reference for it, but I thought was a practice. Can EU regulators enforce principles that are not in the public domain, free of charge, and will they really do so?

6. On a scale from 0 to 100 how grumpy do I sound ? :-D




PS nobody: My colon is fine, thanks for asking. One should never underestimate the importance of proper intestinal health and a good flora. :cool::ok::wink:

Pass or fail!
ElMaestro

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