The DSRU International Working Group on New Developments in Pharmacovigilance

The DSRU’s International Working Group (IWG) has resumed its work, following an extended break due to the pandemic. Bringing together over 65 global experts in pharmacovigilance and pharmacoepidemiology, the IWG aims to identify areas where pharmacovigilance can be strengthened and to produce corresponding documentation or guidance.
Following an initial plenary meeting, the group has identified two areas in pharmacovigilance which require focus:

(i) Causal inference in pharmacovigilance
Causal inference is a method for defining whether a medication causes an outcome.
The document planning phase for this topic commenced in November 2022 with IWG members identifying the need for a scoping document which examines the existing evidence, strengths and weaknesses for looking at causality. Members will begin work on the document framework imminently.

(ii) Data sources in pharmacovigilance
A wide variety of data sources are used in pharmacovigilance and these data sets are often incorrectly treated as if they are equal. Therefore, the IWG decided that a guide should be produced detailing all major data sources, their strengths, limitations and uses.
The planning meeting for this topic was held on 18th January 2023 whilst work on the causal inference document continues.

We will bring you updates as the work of the IWG progresses in coming months.