WG Presentation to FDA

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When: 09:00 EDT, 24Aug2018
Place: GoTo Meeting
Facilitator: Wendy Dobson and Jared Slain
Scribe: Jared Slain
Attendance: Wendy Dobson, Jared Slain, Mary Nilsson, Mat Soukup, Hanming Tu, Susan Duke
Agenda: WG Presentation to FDA

Review of Previous Meeting's Minutes

  • Update: Lilly got response from FDA that included reference to AE whitepaper

WG Presentation to FDA

  • Quarterly FDA meeting that includes non-PhUSE people
  • A lot of people from various offices
  • High priority for Mary in the short term
  • Need FDA people active in whitepaper meetings (at least 1) and more FDA participation in whitepaper review
  • Rough draft for review at next CPE meeting

US Connect - Paper

  • WG visibility at event?

Whitepaper Survey for CSS?

  • How are whitepapers being used? (Survey)
  • How do we get them to the correct people?
  • Who is creating the safety standards in the company?

Half day seminar

  • Mary preparing internally for Lilly (due end of year)
  • Don't know yet about timing (later next year)
  • Begin working on table of contacts

Action Items

  • Mary: prioritizing educational videos and FDA talk
  • Mat: Mat is working on DIA session abstract (2019 June): Statistician's role in safety analyses (ASA Biopharm/PhUSE/DIA)
  • Jared: Poster/Paper at US Connect?
  • Wendy: Keep Wiki updated

Last revision by Jared s,08/26/2018