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RPS 2 Project Update

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

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RPS 2 Project Update

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  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 Iteration 1 08/24/08 - 5/25/09 Requirements Dev Testing Iteration 2 12/18/08 - 08/24/09 Requirements Development Testing Iteration 3 08/25/08 - 01/15/10 Revisit Iteration Ballot Discussion DSTU Ballot Prep DSTU Ballot Ballot Reconciliation

  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 2nd 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?

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