May 5th 2018 Minutes

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Attendees: Mike, Nimita, Melissa, Zach, Bharath, Dragomir, Eunice, Sameer, Hari, Srinivas, Dawn, Catherine, Jasmine, Rinki, Sharon. Sreekanth, Susan

Apologies: Steve, Roxane, Eric, Heather, Ingeborg, Paul

Agenda:

Introduce new members

  • Stella Munuo
  • Sameer Thapar
    • Global Pharmacovigilance Director at Orcle Health supports all the HSGBU products
    • 20 Years in the Pharma area
  • Dawn Kaminski
    • Senior director of strategies at Eclinical Solutions
    • Eclinical Solutions now have a software package Elluminate


Project updates

  • Best Practices for Interactive Analyses for Decision Making and Submission
    • Working on the different parts of the white paper for how to provide interactive analyses to the regulatory agencies
    • Currently working on documentation of validation
    • We are not focusing on a specific application we want to establish what the requirements are from the FDA
    • We are looking to create a general framework
  • Use of Data Visualisation for Subject Level Data Review
    • Focuses on patient summaries
    • Working on the White Paper
  • Use of Data Visualisation for Data Anomaly Detection
    • Plan to have the first speaker at the end of June
    • LW to send out invitations after team review
  • Three FDA groups that were just starting up and thought there may be a collaboration opportunity (any insight?)
    • Paul - I think it is too early for those groups to have external input. Our discussions have focused primarily on discussing and delineating processes and procedures, at this time. If you have a proposal, I can forward it on to the chairs of the groups, since I’m on the three that I think you have referenced
    • Paul will update on their progress


AOB

  • Nimita- Working with companies which are developing interactive solutions
  • Are you covering interactive visualisations with risk based managing
  • Focus on interactive visualisation from an end based user or patient perspective

Next Meeting

  • Start to think about wrapping up towards the end of the year and start new projects
  • Start brainstorming on new project ideas which are different or extentions on the projects we have that relates to DV or ET&T