San Diego Working Group Meeting / Date: 2017-09-12
Time: Tuesday Q2
Facilitator / Ed Helton / Note taker(s) / John Kiser
Attendee / Name / Affiliation
Y / Ed Helton / NCI
Y / Mary Ann Slack / FDA
Y / Lauren Becnel / CDISC
Y / Boris Brodsky / FDA
Y / Geoff Low / Medidata
Y / Julie Evans / Samvit Solutions
Y / Bill Friggle / Sanofi
Y / Jose Galvez / NIH
Y / Hugh Glover / Blue Wave / Parexel
Y / Mihoko Okada / PMDA
Y / Smita Hastak / Samvit Solutions
Y / Bill Gregory / Pfizer
Y / John Kiser / AbbVie
Y / Daisuke Koide / University of Tokyo
Y / Robinette Renner / NCI
Y / Panagiotis Telonis / EMA
Y / Wendy Ver Hoef / Samvit Solutions
J
Quorum Requirements Met: Yes
BR&R SAN DIEGO AGENDA (updated Sept 7, 2017)
Monday
· Q3 Agenda review, identification of reps to joint meetings (PC, CIC), issues to be addressed in joint meetings (so reps are prepared)
o Observations from FHIR connectathon, including Include use cases to be used in the January ’18 Connectathon
· Q4 Business (3-year roadmap)
Tuesday
· Q1 CIC joint with BR&R (need to identify reps); Geoff Lowe to present “Research on FHIR”
· BRIDG 5.0 ISO ballot reconciliation -- cannot be addressed until end of October
· Q2 Open discussion on potential projects
o Thoughts from Ed, Hugh, any others
· Q3-4 BRIDG Architectural Review and FHIR mapping (FDA grant project report)
o Determine scope and actions needed for ResearchStudy, ResearchSubject
Wednesday
· Q1 BRIDG Packaging – working session
· Q2 PQ/CMC requirements mapped to SPL, review any needed CPM and SPL changes (SPL v9)
· Q3 IDMP FHIR proof of concept
· Q4 Business (finalize 3-year roadmap)
Thursday
· Q1 Review with FHIR Marshal on BR&R FHIR activities (ResearchStudy, Research Subject; also
· Q2 BRIDG use in the Moonshot and FDA 21st Century Cures Act; Immuno-Oncology
· Q3 AE FHIR project joint with Patient Care, need to identify several reps; AOB and spillover from other quarters
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