SS P08 20Jan2015 Standard Scripts Project 08 Meeting

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Meeting Record


When: 20 Jan 2015
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Mohammad, Helsinn, Sheryl, Rebeka, Wei, Nancy, Karolyn, Simin, Aiming, Frank, Terry
Excused:

Agenda
  1. CSS Preparation
  2. White paper updates

Minutes

  • PhUSE CSS - Breakout session planned for our project, 4 posters planned for our WG
  • PharmaSUG - 2 presentations/posters planned for our WG (1 general, 1 on qualification process)
  • We discussed version 2's of our completed white papers - probably next year
  • We do have editing support for our white papers (via Lilly)
  • White Paper Updates
    • Outliers/Shifts - working on final version. Will discuss during breakout session. Mary to ask Steve/Mat about FDA review.
    • Adverse Events - working on next draft. Will discuss during breakout sessions.
    • Hepatotoxicity - Draft to white paper project team coming. Will discuss during breakout sessions.
    • QT Studies - Draft to white paper project team coming soon.
    • Questionnaires - Draft to white paper project team coming soon.
    • Special topics - Wei/Mary will likely lead after outlier/shifts done.


  • Last revision by Jmbodart,10/13/2015