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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 | ||
| − | + | *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 | |
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| − | |||
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| − | |||
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2. Discuss | 2. Discuss | ||
| − | + | * Relating one submission to another submission with descriptive text (Japan) | |
| − | + | * Submission unit date (both sent and received) | |
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Revision as of 12:37, 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)
