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MHRA Guidelines on Risk-based Quality Management (RBQM) in Clinical Trials

Reading Time: 5 minutesThis blog was authored by Fiona Maini, Global Compliance and Strategy Principal, Medidata. On January 28th, 2022, the UK Medicines & Healthcare products Regulatory Agency (MHRA) published guidance on clinical trials regarding risk-adapted approaches, risk assessments, oversight, and monitoring activities in two individual documents: Risk-adapted Approach to Clinical Trials and Risk Assessments1 and Oversight and Monitoring […]

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