SS 01Feb2017

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Agenda for Group Sessions in PhUSE / CSS 2017

  • Communicating and promoting
  • How to recruit and retain volunteers
Day Time Organizer Session
Sunday 4 - 5 pm PhUSE On-site Registration
3/19/17 5 - 7 pm PhUSE Opening Session: Welcome and Working Group Overview
7.30 - 9 pm PhUSE Workshop: Introduction to Linked Data and Graph Databases
Monday 8.30 - 10.30am PhUSE CDER Reviewers: Insight into Review and Analysis
3/20/17 10.30 - 11am Break & Networking
11 - 12 pm Standard Analyses and Code Sharing Working Group Breakout Session (Spring Room)
  • 11:00 ~ 11:15 pm Background and trends (Mat)
  • 11:16 ~ 11:30 pm Overview of WG and tour of the WG wiki pages (Mary)
  • 11:31 ~ 11:50 pm Tour of Repository: Structure and Index page (Hanming)
  • 11:50 ~ 12:00 Q&A
12 - 1 pm Lunch & Networking
1 - 4.30 pm US Standard Analyses and Code Sharing Working Group Breakout Session (Spring Room)
  • 1:00 ~ 2:00 pm Updates for each project within working groups (all project leads)
    • P01 - SDA: Script discovery and acquisition (Rebeka M Revis; Alfredo)
    • P02 - RCD: Repository content and delivery (Gustav Bernard; Andrew Miskell; FDA Liaison: Mat Soukup)
    • P07 - CPE: Communication, Promotion and Education (Jared Slain and Wendy Dobson)
    • P08 - ADW: Analysis and Display White papers (Mary Nilsson)
    • P09 - TDF: Test Dataset Factory (Peter Schaefer; TBD))
  • 2:00 ~ 2:30 Communication, Promotion and Education (Mary/Ian Fleming)
  • 2:30 ~ 2:45 Break to reconfigure the room
  • 2:45 ~ 4:30 Break out to small groups in Spring Room
    • Analysis and Display White Papers Project Team breakout session (Mary)
      • 2:45-3:00 Review agenda, make adjustments as needed (Mary)
      • 3:00-4:00 Meet with Best Practices for Data Collection Instructions project team (Mary, Todd)
      • 4:00-4:30 AE white paper follow-ups (gender/pediatric-specific lists, methods for grouping MedDRA PTs (Nhi and Mary)
    • Repository-related project teams breakout session (Gustav/Hanming)
      • Get to know GitHub (Jared)
      • Repository Content Overview (Gustav)
      • Present completed specs and code based on white paper displays (Alex Ford)
      • Present qualification process (Andy)
      • TDF (Peter)
      • FDA JumpStart scripts/Spotfire templates (Rebeka)
5 - 6.30pm Poster Session – Sponsored by:
6 - 7.30pm US Workshop: Code Sharing Utilizing GitHub
  • 10m: Get to know GitHub (Jared)
  • 20m: Script development (Gustav)
  • 30m: FDA Scripts (Rebeca)
  • 30m: Spotfire template (Rebeca)
Tuesday 8.30 - 12pm US Working Group Breakout Sessions
  • Analysis and Display White Papers Project Team breakout session (Mary)
    • 8:30-9:30 Meet with Data Visualizations project team (Mary, Mike Rubison)
    • 9:30-10:15 Hepatotoxicity white paper (Terry)
    • 10:15-10:30 Break
    • 10:30-11:00 Treatment-Emergent white paper (Lisa, Mary)
    • 11:00-11:30 Lab/Vitals/ECGs version 2 white paper (Wei)
    • 11:30-12:00 Summary of next steps for each white paper (Mary)
  • Platform: FDA scripts, qualification process and test environment
    • Scripts in Repository
      • FDA JumpStart scripts (Rebeca) depending on whether Rebeka give the presentation on Monday
      • Non-clinical scripts (Hanming)
      • other scripts (Gustav)
    • Qualification Next Targets and Exercise (Gustav)
      • Exercise the qualification process on selected scripts (Gustav)
      • Develop other scripts into new phases
      • Qualification is on-going process and the qualified scripts could be re-qualified for its new version (expanded feature or coverage)
    • Test environment (SAS and R)
      • SAS Academic on-demand
      • R
3/21/17 12 - 1pm Lunch & Networking
1 - 2pm US Working Group Wrap-up (Our WG and all project participants)
  • Recap from whitepaper and platform
  • Key discussion points
  • Future plan
2 - 2.30pm Break & Networking
2.30 - 3.30pm Industry Panel: Impact of the Guidance on Submissions
3.30 - 4pm Poster Awards and Closing Remarks