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Difference between revisions of "Meeting Minutes 14-Dec-2010"
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1. Review model for | 1. Review model for | ||
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*procedure-type for the application | *procedure-type for the application | ||
*agency-code for the application | *agency-code for the application |
Revision as of 12:39, 11 January 2011
Discussion:
Product information and applicant information was discussed.
More discussion is needed to determine if applicant is related to the submission or application.
Decisions:
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)