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Development safety update report (dsur) pharmacovigilance and safety

Development safety update report (dsur) pharmacovigilance and safety

According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already impleme...

20 slides 13,226
Healthcare
Safety reports rmp risk management plan pharmacovigilance

Safety reports rmp risk management plan pharmacovigilance

A Risk management plan is a document based on safety profile of medicines that collects all pharmaco...

18 slides 6,938
Business
Azierta
Safety reports. addendum to the clinical overview. aco

Safety reports. addendum to the clinical overview. aco

Critical discussion addressing the current benefit/risk balance for the product on the basis of a co...

14 slides 9,332
Business
Azierta