SRI Team Presentation
By n-ohr, Updated
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Could you please verify if any update/action is needed regarding DSUR sumbissions in Spain?
In 2017 we had about 280 queries to answer and 160 SMP QCs so far
When does safety reporting to Thailand MOH has to be stopped?
Does all LECs have to be informed in case of a domestic SUSAR?
We will contact all CCAAs of Spain to receive detailed clarification about the submission of DSURs and SUSARs
A new electronic portal is in place, so the access to it has to be organized and discussed
It took one month to receive all answers and in sum 6 hours for the team to follow up with the CCAAs and local colleagues and additional hours to document and analyse the answers
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