EU ombudsman looking into EMA presubmission meetings [Study As­sess­ment]

posted by Ohlbe – France, 2017-07-20 12:12 (2759 d 20:31 ago) – Posting: # 17571
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Dear ElMaestro,

❝ 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?


I don't think the issue is with scientific advice. This process is quite straightforward and well documented. In addition the MS involved in scientific advice may not be the same which will be (Co-)Rapporteur when the application is submitted.

I think what is being discussed is rather the pre-submission meetings described in question 2.9 here.

Regards
Ohlbe

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