Difference between revisions of "Meeting Minutes 14-Dec-2010"
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| − | + | '''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''': | |
| + | |||
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''': | |
| + | |||
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)? | ||
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| − | + | '''Next meeting topic''': | |
1. Review model for | 1. Review model for | ||
Revision as of 12:35, 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)
