Development Safety Update Reports (DSURs)
The DSUR according to ICH guideline E2F “Note for guidance on development safety update reports” is a common standard for periodic reporting on drugs under development. This also includes marketed medicinal products which are investigated in clinical trials.
In addition to the inclusion of study specific data our DSUR service includes the mandatory literature search and the summary of new and significant safety findings arising from the worldwide scientific literature. Evaluation of publications comprises non-clinical and clinical studies as well as information on drugs of the same class.
We support you in harmonising DSUR and PSUR information in order to present a comprehensive overview of your (investigational) medicinal product’s benefit-risk ratio. Although the DSUR and the PSUR are stand-alone documents with different reporting periods some information might be important for both documents and should be harmonised. For example the evaluation of post marketing data as performed in the PSUR might have implications for clinical development. On the other hand, if clinical trials are conducted with marketed medicinal products, safety findings do also have to be reported in the PSUR. Additionally, the summary of important risks in the DSUR can provide the basis for the safety specification of a Risk Management Plan.
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