Meeting Minutes 14-Dec-2010

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)