Assessment of benefit-risk
Assessment of benefit-risk balance is part of the continuing monitoring required for protection of patients exposed to medicinal products. 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 is a major undertaking and requires expert input from several sources - and this may need to be performed to a punishing timeline.
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.
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