RPS R2 MM 07072009

Regulated Product Submissions | RPS Requirements Subgroup Meetings

Due to a meeting conflicts, please see the schedule for tomorrow’s RPS Meetings below:

7:30 AM EDT RPS R2 Requirements Subgroup– Meeting Postponed to 12:30 PM EDT

12:00 PM EDT RPS R2 Project Status Meeting– Meeting moved to 12:30 PM EDT

Date: Tuesday, July 7, 2009

Time: 12:30 PM EDT – 1:30 PM EDT

Phone Number: 770-657-9270

Participant Passcode: 745896

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

Meeting Notes

• Testing (Jason)– 5 -10 Minutes -- POSTPONED -- The status update was that the testing team will be meeting on July 14, 2009 to discuss the testing findings and will report back on July 21, 2009 to the Project Team as to the testing progress to date.

• Requirements Discussion (Marti)– 30 – 45 minutes -- Reviewed the status of the product inforamtion requirements. There is still questions whether we need product strength and dose form for biopharmaceuticals. The group needs to decide to include product strength and dose form in the iteration 2 requirements for the testing to determine if these requirements meet the intended storyboards for multi-product submission. The Requiremetns Subgroup will need to determine some objectives that need to be met to ensure the requirements are tested during Iteration 2 testing. M.Velezis will work with Dirk Beth to address this concern.

• Project Status - need a status of development and testing to be provided after the leadership meeting on July 13, 2009. G. Williams requested a written status of project activities for an subgroup activities when a project lead was not available for the status meetings. In addition, there will be two sessions planned for the September WGM (currently scheduled for Wednesday).

• ICH Update from Mary Ann Slack -- postponed due to unexpected abscence. This agenda item will be added to teh July 21, 2009 project status meeting (scheduled at 8:00 PM EDT).

Attendance: