RPS Meeting Notes 01262010

Return to RCRIM main page | Regulated_Product_Submissions

Meeting Details

Date: Tuesday, January 26, 2010

Time: 7:30 AM EST – 9:00 AM EST

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

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

Agenda:

RPS R2

1. Brief feedback on ballot process (full report will come in meeting on 9th Feb) - Jason Rock, others?

2. Plans for DSTU testing, discussion in Phoenix and outline proposal - Bob Birmingham

RPS R3

1. Feedback from Phoenix on acceptance of the Project Scope Statement - Marti Velezis/ Ed Tripp/??

2. Project planning, requirements (which would poeple want more detail on at this stage) - Geoff

AOB

1. Any other feedback from Phoenix (what happened about the RASH proposal, liaising with ISO, anything else of interest)

2. AOB

Discussion Notes

RPS R2 Updates

• RPS R2 Ballot Results/Updates - Working through ballot comments; Ballot passed overall, but the negative ballots will need to be resolved; Updates will need to made and further discussion in the WG will need to occur. There will be an overview of the results and discussion of outstanding items at the next meeting on February 9, 2010.
• RPS R2 DSTU Testing Activities discussed during an ad-hoc meeting on Tuesday, January 19, 2010 (Q2). Suggestion to have defined start and end dates for the DSTU testing - identify key milestones - rough schedule would be to be completed by January 2011. In order to provide feedback into the RPS R3 WG - testing should begin in the June 2010 time frame. Next meeting will start as soon as February 16, 2010. Call for volunteers to contact Bob Birmingham, participation/task assignment is mandatory. Suggestion to provide the roles/time commitment for participants and develop a test script template for use by the team members. The testing team should consider developing documentation to aid in describing the task and expectations.

Link to the DSTU Testing Meeting Notes - Media:RPS DSTU Planning - HL7 Phoenix Jan 2010 Notes.doc

RPS R3 Updates

• RPS R3 Project Scope Statement was approved to at RCRIM and Domain Steering Committee. Awaiting for Technical Steering Committee approval. Project can commence activities in the meantime.
• The project planning activities will need to be completed to provide the group with more details about the project. The timeline has been set for January 2011 ballot cycle. Ballot materials will be due at the end of October 2010.
  • Testing Scenarios and testing should be scaled, as appropriate for RPS R3
  • Determine the regional requirements scope and needed time commitment to incorporate them in RPS R3; these requirements will not need to be adopted/agreed upon by the entire team; need to address this in the governance structure. Send out a call for regional requirements and set timelines (given the remaining tasks that need to be completed by the end of October 2010). Requirements should be brought to the WG in a structured manner (i.e., initial discussions should not take place during the working group meetings).
• The project overlap between RPS R2 and RPS R3 will be addressed by the project team - this item was raised by Ed Tripp. Follow-up with Ed Tripp to determine what is needed to address this concern (Action item - Geoff Williams). Project team members should contact Geoff Williams on any position for RPS R2 moving to Normative with respect to activities in RPS R3. Awaiting clarification on FDA position, as the U.S. requirements were incorporated in RPS R2. Work will be done over the next four months to address this concern.
• Suggest that a calendar of other related meetings be documented to provide alternative location to resolve key items face-to-face - please send meetings via listserve.
• Geoff Williams will work on outlining the project plan and logistical issues.

Other Business

• Other topics from Phoenix WGM
  • RASH Project Proposal - There was positive feedback; there is additional research that needs to be done to determine if existing technical solutions can solve the scope. The project is considered tightly linked to the RPS R3 working group meeting. The research should take a couple of weeks to bring back to the group.
  • ISO liaison - there needs to be additional work address the concerns within the RPS WG - 1. Device Group will take an action to meet with a small group to discuss issues with device representation in the ISO TCs and working groups; 2. Raise the issue with RCRIM to have the JIC process issues addressed by the HL7 leadership; 3. Look to engage with ISO TC215 and identify a liaison.
• Next meeting, February 9, 2010 at 7:30 AM EST. NOTE: New Webinar Information will be provided for the next meeting.

Participants

Bob Gatling, FDA, bob.gatling@fda.hhs.gov; Lenore Palma, Datafarm, Inc., Lenore.Palma@DatafarmInc.com; Taku Watanabe, PMDA, watanabe-taku@pmda.go.jp; Mary Padgett, FDA, mary.padgett@fda.hhs.gov; Joerg Lautz, Gruenenthal GmbH, joerg.lautz@grunenthal.com; Geoff Williams, Roche, geoff.williams@roche.com; Yuiko Fukui, PMDA, fukui-yuiko@pmda.go.jp; Mark Gray, FDA, Mark.Gray@fda.hhs.gov; Joyce Gailey, Bristol-Myers Squibb, joyce.gailey@bms.com; Cindy Piccirillo, BMS, cynthia.piccirillo@bms.com; Joel Finkle, ISI, joel.finkle@imagesolutions.com; Bernie Liebler; Tracy Naughton, AstraZeneca, tracy.naughton@astrazeneca.com; Bob Birmingham, Johnson & Johnson, rbirming@its.jnj.com; Uday Karnik, Novartis, uday.karnik@novartis.com; Vishwanath Manegari, Abbott Laboratories, vishwanath.manegari@abbott.com; Tracy Naughton, AstraZeneca, tracy.naughton@astrazeneca.com; Joerg Schnitzler, Astellas, joerg.schnitzler@eu.astelas.com; Joe Cipollina, Pfizer, joseph.cipollina@pfizer.com; Scott Becker, Merck, scott_becker@merck.com; Brent Jones, Chester Springs Consulting, jjonness@comcast.net; Penny Dowd, Genzyme, penny.dowd@genzyme.com; Joerg Lautz, Gruenenthal GmbH, joerg.lautz@grunenthal.com; Marti Velezis, marti.velezis@sonrisaconsulting.com; Jill Geist, Abbott, jill.geist@abbott.com; Bill Friggle, sanofi aventis, william.friggle@sanofi-aventis.com