2012-06-05 RCRIM Call Minutes

Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda Location: Dial: 770-657-9270 Passcode: 7485962# WebEx Info: Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3 If requested, enter your name and email address. If a password is required, enter the meeting password: RCRIM		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

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

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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