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The UK BIO-TRAC study

An evaluation of product and batch traceability in UK clinical practice and reporting of adverse drug reactions

Escher, the Lygature platform for regulatory innovation, and the Drug Safety Research Unit (DSRU) in the United Kingdom, have formed a collaboration to initiate the UK BIO-TRAC study. This project is a follow-up to a previous Escher study in The Netherlands.
 
The UK BIO-TRAC study was launched in December 2016 and aims to assess the challenges of product and batch traceability for biologics in the UK clinical setting and ADR reporting. Within the framework of the UK BIO-TRAC study, hospital pharmacists from the National Health Service trusts throughout England will be surveyed. In addition, a comprehensive assessment of the status of the traceability of biologics in the Medicines & Healthcare products Regulatory Agency’s ADR database will be performed

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