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Difference between revisions of "Meeting Minutes 14-Dec-2010"
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| Line 1: | Line 1: | ||
'''Discussion''': | '''Discussion''': | ||
| − | + | *Product information and applicant information was discussed. | |
| − | Product information and applicant information was discussed. | + | *More discussion is needed to determine if applicant is related to the submission or application. |
| − | |||
| − | More discussion is needed to determine if applicant is related to the submission or application. | ||
'''Decisions''': | '''Decisions''': | ||
| − | + | *Product information will be the superset of requirements at the submission level | |
| − | Product information will be the superset of requirements at the submission level | + | *Jason will provide areas that change in the model before each discussion |
| − | |||
| − | Jason will provide areas that change in the model before each discussion | ||
'''Action Items''': | '''Action Items''': | ||
| − | + | *Taku: Can product name be split up in multiple concepts (e.g. name, route, strength)? | |
| − | 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. | |
| − | Taku: Does product category have sub categories? | ||
| − | |||
| − | Jason: Update model based on discussion. | ||
| − | |||
'''Next meeting topic''': | '''Next meeting topic''': | ||
| − | 1. Review model for | + | 1. Review model for |
| − | |||
*procedure-type for the application | *procedure-type for the application | ||
*agency-code for the application | *agency-code for the application | ||
| Line 33: | Line 24: | ||
*Product | *Product | ||
*Applicant | *Applicant | ||
| − | + | 2. Discuss | |
| − | 2. Discuss | ||
* Relating one submission to another submission with descriptive text (Japan) | * Relating one submission to another submission with descriptive text (Japan) | ||
* Submission unit date (both sent and received) | * Submission unit date (both sent and received) | ||
Latest revision as of 12:48, 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)
