RPS Project Notes24112009

RCRIM | Regulated_Product_Submission

Date: November 24, 2009

Time: 12:00 PM EST – 1:00 PM EST

HL7 Telecon: 770-657-9270 Participant Passcode: 745896

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

1. Review Agenda 2. RPS R2 Activities

• Ballot Activities - January 2010
• Planning for DSTU – Implementation Activities

3. RPS R3 Planning Activities

• Project Scope Statement
• Project Sponsorship
• ICH Requirements
• Other Product – International Requirements
• Regional Requirements

4. Questions?

Discussion Notes

RPS R2 Activities

Ballot Activities - January 2010 - Q1 Tuesday

• FDA is working on the code sets for RPS R2 DSTU Implementation; will feedback information to the RPS R3 activities; there has not been a decision made on RPS R2 testing for devices.

Planning for DSTU – Implementation Activities

• RPS R2 DSTU - FDA has expressed interest to continue with the RPS R2 testing; RPS R3 will need to manage the risks that fall out of the RPS R2 DSTU implementation.

RPS R3 Planning Activities

WGM Q4 Tuesday

• Project Scope Statement - need to work on this for the RPS R3; the process for reviewing this includes several approval steps, including review/comment from the RPS WG, RCRIM WG, Steering Division (review for overlapping standards), and Technical Steering Committee (review for overlapping standards/projects in the ISO/CEN activities). The project scope needs to be approved by all of these groups one WGM prior to taking the standard to ballot.
  • Project Sponsorship - Anyone interested in sponsoring the RPS R3 activities will need to be identified for the project scope statement; once the project sponsorship is resolved, the project team will be identified.
  • ICH Requirements - Media: link to document pending Attached are the requirements submitted by ICH and the scope prioritization based on the November 10, 2009 meeting. Please review and comment on the scope topic areas -- see below.
  • Other Product – International Requirements - are there any additional requirements to be added outside of the 6 areas identified below?
  • Regional Requirements - regional requirements will need to be brought forth as implementations may rely on having them along with the internationally harmonized requirements. Send these forward for incorporation with the existing list of requirements.

Current Scope Topics - Reviewed and pending comments

• Additional Information about the Submission
• Two-Way Communication
• Referencing
• Lifecycle (e.g., Application, Submission, Attribute/Metadata and Element)
• Implementation Requirements
• Miscellaneous (e.g., hierarchy, document groupings and order of files, broken links)

Additional Requirements Discussed:

• Need to know how the product information is handled in R3; pending discussions. Currently RPS R2 references the CPM - CMET R_Product (same as ICSR standard)

• Need to discuss the broken link issues for RPS R3; this may be better understood with the implementation activities.

Project Sponsorship and Participation

• RPS R3 - European participation - interested in reviewing the project governance for the next release to put some structure around how R3 project is run. There needs to be a means for making decisions and resolving them on the project. If stakeholders have requirements they should bring them forth and shepard them through the process.

• If stakeholders are interested in participating in R3 activities (e.g., requirements, leadership), they should contact Geoff Williams, Mark Gray, Joe Cipollina or Bob Birmingham. If there are any additional scope topics/requirements - please send them to the listserve or directly to Marti Velezis.

• There may be some more international requirements from devices (via participation in GHTF); participation/engagement is still unknown, but something that should be tracked by the group.

• Objective: To get the project scope statement drafted (and ready for approval) for the Atlanta WGM and a proposed general timeline for scope items known to date.

NOTE: At this time, no addtional time in the WGM meeting is needed to discuss RPS R3 in January 2010. Note - if addtional time is needed, we need to contact RCRIM Co-Chairs.

Tentative Meeting Schedule

December 8, 2009 – 7:30 AM EST – Agenda: Discussion about the Project Scope Statement and content required; Discuss Project Sponsorship and resourcing for R3;

December 22, 2009 - (*)12:00 PM EST – Agenda: Project Scope Statement Draft Review and Comments

(*) NOTE: Need to discuss changing the time of December 22, 2009 to 7:30 AM EST to accommodate international participation in all regions.

January 5, 2009 – 7:30 AM EST – Agenda: TBD

January 18 – 21 – Phoenix WGM