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 RISK MANAGEMENT REPORT FORM REPORT of ADVERSE FINDING 2019-2025

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[Music] today I hope to convince you that a global database of suspected adverse drug events can provide quality data for the assessment of real-time safety concerns in 2014 the EMA received applications for 100 medicines 82 of which were approved 41 of these were for new active substances and 7 received positive opinion after an accelerated assessment edel elizab was reviewed by an accelerated assessment in 2014 both the FDA and the EMA licensed it for use with rituximab in chronic lymphocytic leukemia and lymphoma CLL affects around four and ten thousand people per year it tends to occur around 70 years of age and it's a slowly progressive disease and therapy is usually conservative until the patient is symptomatic CLL is characterized by an accumulation of cancerous mountain a clonal mature B cells in the bone marrow blood and lymph organs the blood smear on the left is normal while that on the right is from a patient with CLL ideal elizab is a first-in-class phosphoinositid

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