2023-08-02 RWE WG Meeting notes

Date

Aug 2, 2023

Attendees

Name	Organization	Role

Name	Organization	Role
Nick Decker	Roche	Chair Steering Committee member
Rebecca McNall	CDC
Hubert Vesper (Secondary)	CDC	Steering Committee member
Rob Rae	CAP
Gyan Penrose-Kafka	Hologic
Xavier Gansel	bioMérieux	Steering Committee member
Yue Jin	Roche
Walter Sujansky	FDA	Observer

Agenda

Team introductions (10 minutes)
Align “ways of working” / admin topics (meeting time / cadence, raising awareness for the projects & recruiting others to participate, etc)
Review initial proposed projects within the working group; discuss additional proposals
Discuss next steps, how to proceed

Discussion topics

Time	Item	Presenter	Notes

Time

Item

Presenter

Notes

10

Intros

All

Team introductions
Note: Walter Sujansky did not join our call today

30

Scoping Discussion

All

The team has agreed we need to clarify scope of the initiative. Need to level set on the original plans / expectations for the IVD Data Hub

create realistic expectations in terms of the level of granularity that can be provided in the IVD data hub, specifically when it comes to cases
All team members are not familiar with the SHIELD Roadmap; will share for self-learning in prep for our next call
Discussed the possibility of having Keith Campbell join a call with this team to explain more behind FDA’s thoughts on what such an IVD data hub may look like; Riki for LIDR details; + steerco member who is an HCP (perhaps Dr. Luu) → Nick will follow up separately with these colleagues for scheduling

Action items

Review SHIELD Road Map document - See “latest version” on Strategic Plan / Roadmap

Nick will reach out to the colleagues identified above for scheduling a time to join. We’ll book our next meeting accordingly.

Quick decisions not requiring context or tracking

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Decisions requiring context or tracking

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