Pooling WHODrug B3 Meeting Minutes April 2018

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2018-04-25

Agenda


  • Status of white paper public review


  • Discuss future working group meeting schedule


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



Draft White Paper




Attendees


  • Mary Bethala-Pinninti
  • Wendy Dobson
  • MaryAnn Huffert
  • Jane Lozano
  • Marlo Searcy
  • Changhong Shi
  • Vera Voloshin


Not Present:

  • Deb Bauer
  • Greg Campbell
  • Sybille Goetz
  • Malin Jakobsson
  • Susan Kenny
  • Amy Klopman
  • Shannon Labout
  • Joyce Leflar
  • Veena Nataraj
  • Mercy Navarro
  • Diane Piper
  • Laura Savard
  • Nikolaos Sitaridis
  • Lori VanMeter
  • Siva Vobhilineni
  • Lauren White
  • James Zuazo

Meeting Discussion


  • Jane Lozano from PhUSE Steering Committee attended the meeting and thanked the project team for their work on the white paper


  • Jane summarized Steering Committee feedback and the project team adjudicated comments


  • Wendy will target having the revised white paper posted for public review by May 1st with one month for public comment



  • Marlo will cancel the May project team meeting (during public comment period) and the project team will reconvene on June 20th


Action Items


  • Marlo to provide updated draft white paper to Jane and Lisa by end of week


  • Wendy to post white paper for public review (target May 1st with one month review period)


  • Wendy to follow-up with Marlo offline about FDA presentation request


  • Marlo to cancel May project team meeting


Upcoming Agenda Topics


  • Discuss white paper public review comments


  • Discuss next steps and future working group meeting schedule


  • Time-permitting, continue informal sharing around each company’s approach to WHODrug variable and ATC data model for SDTM submission