Pharm Tech Minutes 2017.08.21

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Meeting details

Monday, 21th August 2017, 12:00 - 13:30 CET

Agenda

Welcome

  • Participants
  • Jürgen Brandstätter
  • Jose Teixeira
  • Marc Robberecht
  • Leonidas Tzimis
  • Review and Approve Agenda
  • Approved


CMA received comments resolution

  • Comments received
  • Comments resolved and worked into the profile
  • Comments resolution stored at FTP
  • Question to replace "Point of time" administration by a better term
  • Alternatives:
  • "Single dose": Agreement that this is not correct, because it refers to dose and not to duration
  • "Instantaneous": No entire agreement if this term refers more to "done without delay" or "in a moment"
  • "Single point of time" administration: Decided as a compromise -> Will be changed throughout the profile


CMA accompanying Change Proposals review

  • Change proposals
  • Change proposal CP-PHARM-135 "Introducing "COMMENT" into PADV" required for CMA


CMA profile and CP approval

  • Approval of CMA profile and accompanying CPs
  • Voting decisions:
  • CMA profile is approved to be published with changes discussed
  • Accompanying CPs to CMA are approved to be balloted with changes discussed
  • CP-PHARM-135 "Introducing "COMMENT" into PADV" has been approved to be balloted


Next steps

  • Finalize CMA profile and send to publishing (Jürgen)
  • Finalize accompanying CPs for ballot and organize ballot (Jürgen, Jose)


Pharmacy Technical Committee