Signal detection and evaluation – benefit/risk assessment in safety review meetings

Signal detection and evaluation is an ongoing process, supported by case processing and expedited and periodic reporting. The purpose of signal detection is to identify underlying trends or safety issues that need to be reported to competent authorities. Any changes to the established benefit-risk balance require re-assessment of the product’s safety. In this context, it can be a relatively simple matter of reviewing accumulating evidence and confirming that little has changed. On the other hand, when there is a newly identified important risk, or when new evidence for diminished efficacy arises, the issues can be extraordinarily complex. At such a time, preparation of a comprehensive benefit-risk assessment, involving the concepts presented in the CIOMS IV guideline, facilitates decision-making. Significant changes to benefit-risk balance must be notified to the competent authorities. This may be a matter of extensive discussion between various stakeholders in the company. At such times, having expert independent input to the debate can be crucial.

DADA can conduct ongoing signal detection and evaluation on your behalf. Experienced staff, supported by medically qualified experts, continuously reviews existing safety information in the client’s organisation and in EMA’s database using EVDAS. DADA is registered with EudraVigilance perform signal detection. EMA-trained staff ensure compliance with the rigorous requirements of such a system. DADA may initiate safety review meetings with key stakeholders from the client’s organisation, to discuss these safety findings and decide on appropriate action.