SS P08 04Apr2017 Standard Scripts Project 08 Meeting

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Meeting Record

When: 04 April 2017
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Aiming, Yang, Karin, Simin, Wei, Xiaoping, Nancy, Nhi, Julie Shah,Terry, others I may have missed

  1. CSS summary


  • Update on Data Visualizations project team - planning on patient profiles, data quality and monitoring, and interactive tool for submissions
  • FDA plans to use the AE white paper to help standardize safety reviews
  • Discussed plans for Treatment emergent white paper - will likely outline scenarios and what each company does for each scenario
    • Last revision by MaryNilsson,06/12/2017