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Re: ATLnsider post# 320909

Wednesday, 10/21/2020 3:46:13 PM

Wednesday, October 21, 2020 3:46:13 PM

Post# of 704532

It sounds like the Germany (DE) clinical trial site still has not been updated yet, but there should be "harmonization" across both sites (UK & Germany).



ATLnsider,

I don't know what's going on in Germany.
I am currently in contact with two members of the European Medicines Agency.
One lady is Scientific Administrator-Clinical Trials Information System (CTIS)-Clinical Trials and Manufacturing Task Force-EMA.
The other lady is Scientific Administrator-Clinical Studies and Manufacturing Task Force-European Medicines Agency.

Both are aware of the reply from the PEI (Paul Ehrlich Institut).
I have provided them with additional detailed information about the trial and some statements. Both ladies are very helpful with clarifications on the subject! I hope to be able to comment on the topic one of the next days.
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