12 NOV 2018
Attendees: Kathy, Phil, Sue, Patty, Bob, Fred, Maria, Catherine
Apologies: Drashtii, Thomas
- 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