BR&R SAN DIEGO AGENDA (updated Sept 7, 2017)

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

HL7 BR&R Meeting MinutesSan Diego Working Group Meeting Date: 2017-09-13

Time: Wednesday Q2

Facilitator Ed Helton, Mary Ann Slack Note taker(s) John Kiser

Attendee Name AffiliationY Ed Helton NCIY Mary Ann Slack FDAY Lauren Becnel CDISCY Boris Brodsky FDA

Myron Finseth MedtronicAmy Nordo Duke

Y Geoff LowY Julie Evans Samvit SolutionsY Bill Friggle SanofiY Jose Galvez NIH

Hugh Glover Blue Wave / ParexelY Mihoko Okada PMDAY Smita Hastak Samvit SolutionsY Bill Gregory PfizerY John Kiser AbbVie

Daisuke Koide University of TokyoY Larry Callahan FDAY Catherine Hosage Norman Module 3 SolutionsY Panagiotis Telonis EMAY Wendy Ver Hoef Samvit Solutions

Elaine AyresY Mead Walker Mead Walker Inc.

Julie James Bluewave / Parexel

Quorum Requirements Met: Yes

Gunther presented on PQ/CMC

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