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Article

Risk-Based Quality Management (RBQM) Requirements Explained

Missy Lavinder

FDA has placed ICH E6 (R2)—a revision to Good Clinical Practice (GCP)—in the federal registry. ICH E6 (R2) makes explicit the responsibility of the Sponsor to understand and actively manage the risks to quality in clinical trials using a Risk-Based Quality Management (RBQM) approach.

Download this article to learn about:

The new requirements for RBQM in clinical trials
How RBQM can benefit your clinical development program
Processes your CRO should have in place to ensure compliant RBQM
How RBQM affects clinical monitoring strategies