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)