Samantha Lane (Drug Safety Research Unit [DSRU])

Understanding the evidence used in drug product withdrawals

14 December 2023 | By Samantha Lane (Drug Safety Research Unit [DSRU])

Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.

Different colours and types of pharmaceuticals (pills, tablets and capsules)

article

How can evidence-based medicine (EBM) methodology support drug withdrawals?

20 July 2022 | By Samantha Lane (Drug Safety Research Unit [DSRU])

In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…

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Samantha Lane (Drug Safety Research Unit [DSRU])

Understanding the evidence used in drug product withdrawals

How can evidence-based medicine (EBM) methodology support drug withdrawals?