Pooling WHODrug B3 Meeting Minutes December 2017

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2017-12-13

Agenda


  • FDA Guidance Updates


  • Discuss additional pooling options (if any)


  • Determine pooling options to include in the draft white paper and any order of preference if applicable


  • Next steps to start drafting white paper, Collaboration Options


  • Time Permitting: Informal sharing around each company’s approach to WHODrug variable and ATC data model for SDTM submission

Attendees

  • Deb Bauer
  • Mary Bethala-Pinninti
  • Greg Campbell
  • Wendy Dobson
  • MaryAnn Huffert
  • Malin Jakobsson
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Joyce Leflar
  • Jane Lozano
  • Mercy Navarro
  • Diane Piper
  • Laura Savard
  • Marlo Searcy
  • Changhong Shi
  • Lori VanMeter
  • Siva Vobhilineni
  • Vera Voloshin
  • Lauren White
  • James Zuazo

Meeting Discussion

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Action Items

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Upcoming Agenda Topics


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