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Meeting Minutes 14-Dec-2010

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  • Product information and applicant information was discussed.
  • More discussion is needed to determine if applicant is related to the submission or application.


  • Product information will be the superset of requirements at the submission level
  • Jason will provide areas that change in the model before each discussion

Action Items:

  • Taku: Can product name be split up in multiple concepts (e.g. name, route, strength)?
  • Taku: Does product category have sub categories?
  • Jason: Update model based on discussion.

Next meeting topic:

1. Review model for

  • procedure-type for the application
  • agency-code for the application
  • application tracking number for the application
  • submission tracking number for the submission (i.e. regulatory activity)
  • grouping number for the submission (i.e. regulatory activity)
  • mode for the submission (i.e. regulatory activity)
  • Sub types for Submission (e.g. PAS, CBE)
  • Product
  • Applicant

2. Discuss

  • Relating one submission to another submission with descriptive text (Japan)
  • Submission unit date (both sent and received)