12 NOV 2018

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Attendees: Kathy, Phil, Sue, Patty, Bob, Fred, Maria, Catherine

Apologies: Drashtii, Thomas

Agenda:

Projects update

  • Any projects with update news
    • Define File - Recommendations are posted on the Send forum and on the Wiki page we haven't discussed a white paper
    • What is defined used for? could be an interesting paper to create and read
  • FDA Business rules have been updated in October


  • SEND Survey request from CDISC
    • Requesting information on weather the CDISC standard was being utilised by companies outside of the US
    • In the last survey we didn't collect the country
    • If you need to get submissions to the FDA it doesn't matter what country you're from
    • Patty to follow up with Scott
    • We will use both PhUSE and CDISC mailing list to distribute the survey in December/January

2) Deliverables review – status and planning for run to CSS. - The steering committee is asking about our deliverable plans, because they are getting a little backup in the review schedule.

    • A heads up on when the deliverables are coming in would allow PhUSE to arrange the review a little better as last week we had 4 deliverables to review
    • Sue and Patty to let Wendy know that they will not post more than two deliverables a month to the SC

3) If Steve Polly can join us, there is a industry proposal for a visualisation project from GSK that might be a PhUSE candidate. Would like your opinion. If Steve isn’t available we can have a look next meeting (Dec 10)

    • EFPIA decided not to take this as a project
    • Could this be a PhUSE project?
    • Visualisations on the conclusion of the projects the next step after SEND
    • Andy Harol from GSK is willing to present this to us on December 10th

4) Meeting Schedule: Should we move to bi-weekly in Jan to prepare for US Connect (Feb) and CSS (June).

    • Debrief on US Connect in early March then decide when to go bi-weekly