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 , a dynamic Italian CRO headquartered in Mesagne (BR), not only delivers high-quality pharmacovigilance (PV), quality,...

In July 2025, the European Medicines Agency (EMA) released an updated version of the Sponsor Handbook for the Clinical Trials Information...

If you need support in pharmacovigilance activities for your profit or non profit clinical trials, do not hesitate to contact us at our...