EU ombudsman looking into EMA presubmission meetings [Study Assessment]
Hi Hötzi,
I skim a few newsletters from time to time, saw it mentioned on one of them.
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.
❝ 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.

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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- EU ombudsman looking into EMA presubmission meetings ElMaestro 2017-07-19 20:24 [Study Assessment]
- EU ombudsman looking into EMA presubmission meetings Helmut 2017-07-20 01:54
- EU ombudsman looking into EMA presubmission meetingsElMaestro 2017-07-20 10:09
- EU ombudsman looking into EMA presubmission meetings Ohlbe 2017-07-20 10:12
- EU ombudsman looking into EMA presubmission meetings Helmut 2017-07-20 01:54