RPS R2 MM 090623
Jump to navigation Jump to search
Date: Tuesday, June 22, 2009
Time: 7:30 AM EDT – 9:00 AM EDT
Phone Number: 770-657-9270
Participant Passcode: 745896
- Overview of Project Status (if available)
- Progress on Product requirements (from last week)
- Review of storyboard – Multi-product Submissions (see below)
- Next Meeting
- Discussions regarding ICH requirements and the impact on RPS R2 – the discussions will be captured and storyboards will be placed in queue for LC2 discussions.
- Discussions of Product Information and its relation to Keywords should be discussed at the development subgroup meeting once the requirements are finalized.
- Product Information – final draft was distributed for review, comments are requested for the next meeting on July 7, 2009. We are removing agencyProducureCode, doseFormCode and productStrengthCode and all associated storyboards from R2 – as they are not required by the RPS R2 objectives outlined in the project scope.
- Schedule of Requirement activities leading up to September 2009 WGM
* Finalize Product Information Requirements
* Discuss and Finalized requirement documentation for Manufacturer information
* Support revisions of requirements based on Testing activities
* Finalize ballot materials for review prior to ballot deadlines.
- Next week’s meeting will be cancelled. We will resume product information discussions July 7, 2009 and address any issues identified by the group in the next two weeks.
- Next Project Status call will be on July 7, 2009 at 12:00 PM EDT – Request to confirm agenda for that meeting.