EU ombudsman looking into EMA presubmission meetings [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2017-07-19 22:24 (2443 d 14:01 ago) – Posting: # 17562
Views: 5,430

Hi all,

Strategic inquiry into pre-submission activities organised by the European Medicines Agency

That could be a bit of a stinker. But from the way it is worded I am almost of the impression that the ombudsman has the wrong idea of how scientific advice is usually undertaken and what the purpose is. Obviously, there is an aspect of transparency to discuss, but the sentence "there is still a risk that pre-submission activities create, in the eyes of the public, at least some perception of bias" is surprising to me.
Anyways, if anything is perceived this way then the ombudsman clearly needs to react.

My own experience is that regulators are fairly good at mentioning very early in SA procedures that it does not involve assessment, and that assessment will only be undertaken after submission (they say/write/express that on a regular basis nationally as well as at EMA).

Do some of you experts out there see bias arising out of taking scientific advices, or do you have some ideas what the real background of all this is?

Pass or fail!
ElMaestro

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