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Difference between revisions of "RPS R2 MM 090623"
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| + | Regulated Product Submissions | RPS R2 | ||
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* 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 regarding ICH requirements and the impact on RPS R2 – the discussions will be captured and storyboards will be placed in queue for LC2 discussions. | ||
Revision as of 03:30, 24 June 2009
Regulated Product Submissions | RPS R2
- 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.
