RPS R2 MM 090623

Regulated Product Submissions | RPS Requirements Subgroup Meetings

Date: Tuesday, June 22, 2009

Time: 7:30 AM EDT – 9:00 AM EDT

Phone Number: 770-657-9270

Participant Passcode: 745896

Webinar: http://www.mymeetings.com/nc/join.php?i=SA300482&p=RPS2&t=c

Agenda:

• Overview of Project Status (if available)
• Progress on Product requirements (from last week)
• Review of storyboard – Multi-product Submissions (see below)
• Next Meeting

Notes:

• 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.