REFLECTION PAPER Final
Reflection Paper on Risk-Based Quality Management in Clinical Trials
ABSTRACT — EDITORS' SUMMARY
EMA position on RBQM. Critical-to-quality factors, risk proportionality, the philosophy underneath every operational section of E6(R3) §3.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-based-quality-management-clinical-trials-superseded_en.pdf ↗ RELATED · SAME AUTHORITY