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I haven't joined any meetings yet (but definitely will in the future) so this question might have already been answered at a meeting.
When looking through the minutes there seems to be a focus only on submitting to FDA and the content of their Technical conformance guide and other submission documents.
Is PMDA and NMPA not also in scope for this working group since they also require eData submissions?
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Hi All!
Ari from Novo Nordisk here :)
I haven't joined any meetings yet (but definitely will in the future) so this question might have already been answered at a meeting.
When looking through the minutes there seems to be a focus only on submitting to FDA and the content of their Technical conformance guide and other submission documents.
Is PMDA and NMPA not also in scope for this working group since they also require eData submissions?
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