SRI Team Presentation

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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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