Meeting Minutes - 19.Nov.2015 (2 replies and 1 comment)
Link to:
Minutes - word version: http://1drv.ms/1OdNXaW»
Antoinette's RAPS workshop summary: http://1drv.ms/1OdNSUD»
Antoinette's RAPS workshop package: http://1drv.ms/1OdNW6K»
Link to definition of terms: https://uanotau.sharepoint.com/test/_layouts/15/start.aspx#/SitePages/DIA%20EDM%20Reference%20Model%20-%20Devices.aspx»
ID: [email protected]»
PW: DevicesTerms
Obviously MOM are from meeting 5.Nov.2015 not from 19.Nov.2015
(if any)
Example was prepared on tab Regulatory Admin where the additional column (L - Definition / Purpose) was inserted. The approach would be – make it simple, use the existing definitions where possible and not to go into regional/ country specifics.
It would be appreciated if the workload can be widespread within the team to easily cover all items
-03
-04a
-09b
-10
Romuald will take the 1st look and suggest an approach leveraging the work done in Quality.
The result of the discussion with the Quality Model team was: they did it one by one.
Romuald prepared a starting point file and agreed to send it all participants of this call.
Everyone will pick one term and provide a definition back to Romuald before next call. This should kick off the process.
-MEDTECHEUROPE
(See links below)
She did a research and put together the package of documents /ppt etc../ for workshop attendees and shared it with our MD Reference Model Forum.
Enclosed please find a “Summary of content” presented during meeting– xls.
Romuald: Consider if it necessary to be share the complete content (zip file from AA) with the group.
-Cardinality
-Labeling - contains some meta data fields together with draft proposal for Cardinality
-Non-clinical - contains proposed meta data fields (without info for M/O)
-Clinical – same as Non-clinical - contains proposed meta data field
Ongoing