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)