End to End RBQM Education

Project Scope

Provide community forums for presentation and discussion of RBQM-related topics to support industry education. Topics considered include: What are CtQs?, RBQM and Technology, Risk Assessments, Central Monitoring Analytics, QTLs, AI/ML, and RBQM-related change management.

Problem Statement
Industry wide, there is still a need for general education on RBQM – what it is, what are the components, how to effectively implement RBQM, etc. There is also a lack of feedback from the FDA on RBQM practices implemented, and, based on discussions with the FDA, there may be a need for education in collaboration with the FDA.

Problem Impact

Because of misconceptions and misunderstanding of RBQM, many companies have delayed implementation of RBQM practices. RBQM concepts have the possibility to meaningfully improve data quality and efficiency across many functions (data management, medical monitoring, clinical operations) and processes (e.g. administrative activities); however, due to misunderstanding of RBQM, many functions do not implement risk-based approaches.

Project Leads	Email
Ann Fleenor, Astellas	ann.fleenor@astellas.com
Jennifer Krohn, Gilead	Jenn.Krohn@gilead.com
Shawntel Swannack, Emmes	sswannack@emmes.com
Alex Pearce, PHUSE Project Assistant	alexandra@phuse.global

CURRENT STATUS Q4 2024
Regrouped with new leads Ann, Shawntel and Jennifer Reviewed and edited current member roster and email distribution list Gathered several Community forum topics as part of RBQM education focus

Objectives	Timelines
Produce a webinar series	Q4 2025 – Q4 2025