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    Assessing Benefits Versus Risks in Europe--the New Focus in Pharmacovigilance

    Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug's benefits outweigh its risks. 1 Due to the heterogeneity of the data under review (e.g., toxicological, efficacy and safety), all previous approaches usin...