At the recent Pharmaceutical Information & Pharmacovigilance Association (PIPA) annual conference, pharmacovigilance professionals had the opportunity to exchange best practices and learn from each other at a round table session where cases of three very different pharma companies were presented. Cases from a big pharma, a small pharma, and a generics pharma company served as a broad foundation for engaging and insightful discussions around approaches to signal management, i.e. early detection of adverse drug reactions.
It was reassuring to note that there are many similarities across the three companies in the way signal management is approached. All companies rely on tracking systems built in e.g. Excel, and all have well defined processes in place, including at what points literature searches are performed.
However, one difference that stands out in the approach of the big pharma company is that the signal management process is handled by different parts of the organisation, e.g. the UK team does signal DETECTION only - and only for certain products. These are UK specific products and global products where there are issues. Another difference is that, unlike the generic and small pharma, the pharmacovigilance professionals in the big pharma company do work closely with Regulatory Affairs and the Medical Information department around signal management.
The generic drug manufacturer at the session is under regulatory obligation to have signal management in place for approx. a third of their products. Given that generic drug manufacturers make less profit than big pharma, the comprehensiveness of the signal management processes needs to be carefully balanced against costs.
Since signal management requirements vary across the world the generic manufacturer manages the process locally in order to avoid doing unnecessary work. Some countries have no requirements for signal management, whereas in Europe all documentation needs to be recorded. In the US selected documents need to be recorded, as recording “too much” could increase the risk of litigation.
Representative from the generic pharma company felt that their signal management process could be improved through automation, e.g. part of their tracking spread sheet could be auto-populated from databases, and scheduling of key activities could be automated.
The small pharma company have a simple fit-for-purpose process in place which included literature searches at different stages.
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