DIA 2023 Topic: The Industry-Wide Definition for RBQM

At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the need for clear processes for reviewing audit trails, overseeing decentralized clinical trial (DCT) data, the impact of ICH E6(R3) on these areas, and the need for an industry-wide definition of Risk-Based Quality Management (RBQM).

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From Signature to System: Why E6(R3) Raises the Bar For years, informed consent has too often...

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RBQM for the Mid-Market Explained

Mid-market sponsors are expected to meet the same ICH E6(R3) standards as large pharma, often with...

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5 Myths Mid-Market Teams Believe About RBQM and What ICH E6(R3) Actually Requires

Risk-Based Quality Management (RBQM) is no longer a future-state concept. Under ICH E6(R3), it is a...