EU ombudsman looking into EMA presubmission meetings [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2017-07-20 12:09 (2768 d 07:30 ago) – Posting: # 17570
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Hi Hötzi,

❝ how did you find this “gem”?


I skim a few newsletters from time to time, saw it mentioned on one of them.

❝ Well, it should have taken her max. five minutes to dig this one out.


Funny, I sent that link to the journalist yesterday.

There must be something here which triggered the ombudsman, possibly a complaint.
But as I wrote the journalist, this sentence can be totally perceived the wrong way:
"Following the Agency’s advice increases the probability of a positive outcome."

Take one step back and read it again. An agency saying: If you transfer muchas Euros to our accounts and show up for a meeting then your chances of approval will be higher.

I do not know how the term coercion is perceived outside GCP, but this could be one such case. :no:

Pass or fail!
ElMaestro

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