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