Project Or Work Group Meeting Minutes s4

HL7 BR&R Meeting Minutes Call Number: +1 770-657-9270 Participant Code: 7485962 Date: 2017-12-12 Time: 10:00 – 11:00 am Eastern Time Facilitator Ed Helton Note taker(s) Wendy Ver Hoef Attendee Name Affiliation Y Ed Helton NCI

Elaine Ayres NIH

Nagesh Basham

Lauren Becnel CDISC

Boris Brodsky FDA

Julia Chan

Jean Duteau

Julie Evans Samvit Solutions Y Joel Finkle Acuta Y Myron Finseth Medtronic

Bill Friggle Sanofi

Jose Galvez NIH

Hugh Glover Blue Wave / Parexel

Bill Gregory Pfizer Y Norman Gregory FDA

Smita Hastak Samvit Solutions Y Catherine Hosage Norman Module 3 Solutions Y Ginny Hussong FDA

Julie James Blue Wave / Parexel

John Kiser AbbVie

Adam Kroetsch FDA

Brent Marquard

Lloyd McKenzie Gevity

Bob Milius NMDP NMDP

Michelle Miller

Don Palmer

Y Vada Perkins Indentifica

David Pike

Y Robinette Renner NMDP

Scott Robinson

Mitra Rocca FDA Y Gary Saner Reedtech Y Mary Ann Slack FDA Y Rik Smithies EMA

Lise Stevens

Panagiotis Telonis EMA Y Shigeki Toge

Y Wendy Ver Hoef Samvit Solutions

Ulrike Wagner NCI/FNLCR Y Mead Walker Mead inc Y Shifu Zhao FDA, CBER J Quorum Requirements Met: