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Monday, February 12, 2024 3:52:53 PM
”2.1 Deliver predictable and reliable operational performance having defined our priority improvements for our core services to ensure swift and robust decisions on medical products, safety signals and compliance.
Identify service improvements across all priority areas with robust plans for implementation and effective change management to be in place by end Q4 [2023]
Eliminate current service backlogs by end of Q4 [2023] keeping stakeholders up-to-date.
Deliver phase one of our innovation-enabling and risk-proportionate medicines compliance strategy including the development of a pilot project for an outcome-based model by end Q4 [2023]
What do they mean by risk-proportionate?
….Our explicit commitment to ‘risk-proportionate regulation’ also represents a significant intent to increase regulatory oversight on high-risk medical products, applications and indications, especially in relation to new technologies, with a parallel reduction in regulatory oversight on products where there is clear evidence of a lower risk to patients.
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