WG6 Tcon5 Meeting minutes 07022012

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Standardization Roadmap Team Tcon # 5 July 2, 2012, 10 am EST

Member Attended? (x=yes)
Gitte Frausing, Novo Nordisk X
Bob Dorsam, FDA X
Alain Nanzer, Roche
Deborah Sholtes, FDA
Lou Ann Kramer, Eli Lilly
Jerker Ringstrom, SixSteps AB
Geoff Mann, SAS Institute
John Anderson, Novo Nordisk
Natalia Smeljanski, Merck
Lynda Sands, GlaxoSmithKline X
Debra Oetzman, Covance X
Sarah Obbers, Janssen Research & Development

Agenda: Discuss the Roadmap Prioritization Effort

  • Those in attendance shared the current state of their individual efforts to obtain input on the prioritization list.
    Members were at varying levels of completing the prioritization task. More time is necessary to get company feedback from all members. The Roadmap will be finalized later in the summer. All members should actively pursue feedback from companies if they have not already done so.

-Bob and Gitte shared their finalized prioritization lists
-Some rationales underlying individual’s prioritization were discussed. Members should capture these on their worksheets for potential use when constructing the e-paper.
-Post meeting note: Though the Roadmap will be finalized toward the end of summer, members should be on the lookout for subject matter experts for each part of the roadmap

  • The group agreed on an effort to compile all company/Agency feedback into a single worksheet.

A.I.'Bob will compile prioritization data from members.

-All members should send your company’s prioritization worksheet to Bob with a cc to Gitte.

  • The group agreed that company identities would remain anonymous when compiling data. Identities would be used only in a case where a clarification was necessary.
  • Gitte suggested that we seek input on the prioritization list from other members of Working Group 6.

Bob will contact Tim for feasibility.

  • Gitte suggested that a blank template of the worksheet should be posted on the Wiki for companies to provide input.

A.I. Gitte will contact PhUSE about posting this file to the Wiki and post the sheet.

The group agreed that, due to member’s vacations, the next meeting will be held on Tuesday, July 24th at our regular time (10 am EST). Bob will send an Outlook Invite to the group.

Last revision by Dorsamr,07/3/2012