1. RPS 2 Project Update Mary Ann Slack, FDA Presentation to HL7 RCRIM January 12, 2009

2. Background RPS 1 - Normative Ballot Passed May 2007 - ANSI Standard 2008 RPS 1 Goal - Create a data exchange model that can be used for the submission of any regulated product Framework to allow sponsors to identify and catalog their content Reviewers should be able to consistently identify and locate specific information What RPS 1 Supports Document Lifecycle Reuse of documents across applications Product/submission management Submission lifecycle Computer aided review Allows for regional/product differences

3. RPS 2 Project Project Kickoff meeting – July 2008 Scope - Enhance existing RPS release 1 in a two phase effort ultimately intended to yield a global standard. The first phase will include: Two-way communication Minutes and general correspondence (related to two-way communication) including pre-submission information · Referencing in backbone (Master Files, Other submission/application, Pre- submission) Hyperlinking to other content (NOTE: deferred to future phase) Providing information about the submission (e.g. meta-data, information currently collected on application forms) A second phase will be required to include additional international requirements

4. 2008 2009 2010 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Requirements Iteration 1 Dev Testing Iteration 2 Requirements Development Testing Iteration 3 Revisit Iteration Ballot Discussion DSTU Ballot Prep DSTU Ballot Ballot Reconciliation 08/24/08 - 5/25/09 12/18/08 - 08/24/09 08/25/08 - 01/15/10

5. RPS 2 Project Composition RCRIM RPS Workgroup Community of participants in the RPS project Progress updates and issues discussed Meets every other Tuesday 7am/12noon/8pm Eastern Requirements Team Mart Velezis, Team Lead Requirements gathering, storyboards, use cases Meets every Tuesday 7:30 – 9:00 am Eastern Development Team Jason Rock, Team Lead Model development from requirements Utilizes RCRIM RPS WG meeting Communications Team Mary Ann Slack, Team Lead Communications and outreach needs Meets the 2 nd Thursday of each month 7:30am Eastern, subject to change with participant location Testing Team Dirk Beth, Team Lead Test planning & execution Meets every other Tuesday 10am Eastern NOTE: All call-in information is posted on the HL7 RPS wiki site

6. Current Activities Requirements Status Iteration 1 – Complete Use cases cover the areas of 2-way communication, additional information about the submission Use cases & examples located at HL7 RPS Wikipedia site Iteration 2 – In Progress Requirements areas in iteration 2 will be multi-product submissions & multi-regulator submissions To be addressed – level of complexity in above areas to be covered in Iteration 2 vs Lifecycle 2 Schedule Iteration 1: July - November, 2008 Iteration 2: November, 2008 – January, 2009 Activities Scheduled For Orlando Tuesday, Q2, Parlor 264 Tuesday, Q3, Fuschia

7. Current Activities Development Status Iteration 1 – Complete Schedule Iteration 1: November - December, 2008 Iteration 2: February - April, 2009 Activities Scheduled For Orlando Monday, Q3 & Q4, Salon VI, education and development review

8. Current Activities Testing Status Iteration 1: Kicked off, 3 meetings held, last with tool vendors to determine tools ready for testing Schedule Iteration 1: January – May, 2009 Iteration 2: May – August, 2009 Activities Scheduled For Orlando Tuesday, Q1, Parlor 974 Objectives – Test planning, process, tools overview, special testing requirements

9. Current Activities Communications Status Established Communications Workgroup Slide set from which stakeholders can extract slides to address audiences at the appropriate level – Started, in progress Schedule Ongoing identification and addressing of communications/education needs Activities Scheduled For Orlando Wednesday Q2, Salon VI Notes: no audio/visual support for this meeting; may be superceded by continued Requirements work if needed to stay on schedule.

10. Other Activities ICH Draft Requirements Review Informal activity requested by ICH Development and Requirements Team Leads commented on ICH requirements set as to which are addressed in RPS 1, which are in scope of current work on RPS 2, which need further clarification

11. Where to Find Information HL7 RPS Wikipedia site: wiki.hl7.org, username: wiki, password: wikiwiki From the main page, select Regulated Product Submissions under the Projects category H7 RPS listserv All call-in information may be found on the HL7 RPS wikipedia site

12. Questions?