RPS R2 MM 070142009

Regulated Product Submissions | RPS Requirements Subgroup Meetings

Meeting Agenda:

• Finalize Product Information requirements
• Other?

Date: Tuesday, July 14, 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

Meeting Notes: To address all of the discussions on the listserve regarding new requirements (e.g., broken links, etc.) – I fully support the discussions that are defining new requirements, however the topics are not in our current scope and should be captured for future discussions. (Note – since the meeting Joel Finkle has posted the discussion on the Wiki). The requirements group needs to focus on completing the Lifecycle 1 project scope (i.e., two-way communication, referencing and additional information about the submission to support those two areas).

There was a request/suggestion that we need to have a face-to-face to discuss the pending scope items to determine the next steps. The next face-to-face discussion is scheduled for the Atlanta WGM in September 2009. We will need to request a quarter to address future scope planning (if it is not already scheduled). The RPS meetings are currently scheduled for Wednesday Q1 and Q2.

Product Information – the group finalized the attributes for a Regulated Product (including making changes to the definitions). The product information will be available for the development team to finalize how best to deal with the current product requirements for Iteration 2. We need to remove all dose and strength information from requirements artifacts (including the storyboards) – that information may resurface with future requirements.

Media:RPS R2 Product 14072009.doc

How do the product information intersect with the Common Product Model (CPM)? These requirements may be brought to the CPM project team for consideration in a product CMET or the requirements may just be handled directly in the RPS message, that will be a design decision of the development team.

In order to ensure that the product information is tested, the requirements subgroup would like to work with the testing group to set forth some testing objectives and/or scenarios for testing in the following areas:

Combination Products, Trans-BLAs and Bundled Submissions need to be tested with regards to the product information. Examples include: a combination product - how do you use typeCode to define the product.

Now that the product information has been finalized for this lifecycle, we will not reschedule the requirements subgroup meetings unless there are changes resulting out of the development or testing subgroups that need to be incorporated in the requirements artifacts.

Next meeting will be on July 21, 2009 at 8:00 PM EDT (this will be the project status meeting – we will report our updates).

Attendance: TBA