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2012-06-05 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda

Location: Dial: 770-657-9270 Passcode: 7485962#

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Date: 2012-06-05
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation
x Becky Angeles ScenPro
x Isabelle Dezegher PAREXEL
x Frank Faunce Abbott Laboratories
x Smita Hastak Scenpro
x Ed Helton NCI
x Wayne Kubick CDISC
x Jay Levine FDA
x Keith Thomas i4i
x Ed Tripp Edward S. Tripp and Associates
x Wendy Ver Hoef Scenpro
x Steve Ward Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair


Agenda Topics

  1. Agenda review and approval
  2. Approve meeting minutes from WGM
    Monday May 15, 2012
    Tuesday May 16, 2012
    Wednesday May 17, 2012
  3. Harmonization Proposals from RPS (approval of 6, 7 and 8)
    1. Context of Use
    2. Document Type
    3. Regulatory Category
    4. Regulatory Status
    5. Keyword
    6. Regulatory Review Time
    7. Regulatory Product Category
    8. Related Application Reason
  4. Review Agenda for WGM for Baltimore
    RCRIM Working Group Meeting Agendas

Supporting Documents
See links above


Minutes/Conclusions Reached:

  1. Agenda review and approval
    No changes were made to the agenda
  2. Approve meeting minutes from WGM
    There are corrections that need to be incorporated in the minutes. Ed Tripp will update the minutes and RCRIM will vote electronically on approval of the WGM minutes from Vancouver.
  3. Harmonization Proposals from RPS (approval of 6, 7 and 8)
    RCRIM needs to approve new harmonization proposals (6, 7, and 8) for the upcoming harmonization meetings. Proposals 1-5 have already been reviewed and approved by RCRIM.
    Keith reviewed the proposals on Regulatory Review Time, Regulatory Product Category and Related Application Reason. He explained that Related Application Reason is broader than a link to a document and allows linkage between applications. When ask about the need for Regulatory Review Time, Keith explained that this is an EU request. The submitter will enter the time they think is appropriate, however, the agency may not acct the value.
    A motion was made by Steve Ward and seconded by Ed Helton to approved the three proposals
Proposal Affirmative Votes Negative Votes Abtain
6 7 - 1
7 8 - -
8 8 - -

Ed Tripp will post the proposals on the Harmonization site

  1. Review Agenda for WGM for Baltimore
    Ed reviewed the agenda and noted the changes for joint meetings with Patient Safety and CIC.
  • Adjourned 10:43 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Post Harmonization Proposals Ed Tripp 6/6/2012
Update minutes and create electronic poll Ed Tripp 6/14/2012

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Approve meeting minutes from 2012-06-05_RCRIM_Call_Minutes
  3. Approve publication request from RPS
  4. Other Items

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