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Writing the Annual Safety Report (DSUR) under the EU CTR: Cumulative Safety Assessment focus
The Annual Safety Report (or Development Safety Update Report) is an annual report that summarizes and evaluates the safety of a drug under development to provide an annual review of safety information and identify any new safety issues that could affect the drug's benefit-risk balance.  Among all the elements outlined in the ICH E2F guideline , there is one section that gives real purpose to the Development Safety Update Report (DSUR): the cumulative safety assessment . Whi

ClinOpsHub
26 novTempo di lettura: 2 min
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The Importance of Pharmacovigilance for Investigational Medicinal Products in the Pre-Marketing Context - How ClinOpsHub can support you
If you need support in pharmacovigilance activities for your profit or non profit clinical trials, do not hesitate to contact us at our...

ClinOpsHub
11 dic 2024Tempo di lettura: 2 min
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