Difference between revisions of "Meeting Minutes 14-Dec-2010"
(Created page with "Discussion: Product information and applicant information was discussed. More discussion is needed to determine if applicant is related to the submission or application. Decisio...") |
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| − | Discussion: | + | == Headline text ==Discussion: |
Product information and applicant information was discussed. | Product information and applicant information was discussed. | ||
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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: | + | == Headline text ==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: | + | == Headline text ==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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Taku: Does product category have sub categories? | Taku: Does product category have sub categories? | ||
| + | |||
Jason: Update model based on discussion. | Jason: Update model based on discussion. | ||
| − | Next meeting topic: | + | |
| + | == Headline text ==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 | ||
| + | |||
• application tracking number for the application | • application tracking number for the application | ||
| + | |||
• submission tracking number for the submission (i.e. regulatory activity) | • submission tracking number for the submission (i.e. regulatory activity) | ||
| + | |||
• grouping 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) | • mode for the submission (i.e. regulatory activity) | ||
| + | |||
• Sub types for Submission (e.g. PAS, CBE) | • Sub types for Submission (e.g. PAS, CBE) | ||
| + | |||
• Product | • Product | ||
| + | |||
• Applicant | • Applicant | ||
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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) | ||
Revision as of 12:34, 11 January 2011
== Headline text ==Discussion: Product information and applicant information was discussed.
More discussion is needed to determine if applicant is related to the submission or application.
== Headline text ==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
== Headline text ==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.
== Headline text ==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)
