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The working group contains two work streams with different areas of action: one focuses on improving signal management processes and the other on novel methods for safety signal detection.
It reports regularly to the Pharmacovigilance Risk Assessment Committee (PRAC).
For more information on signal detection and the EU signal management process, see:
The processes work stream provides expert input to PRAC in order to continuously improve:
This work stream meets ad-hoc.
The methods work stream reviews new developments in the methods used to detect safety signals.
It tests and implements novel techniques to ensure that they meet the current demands of the European medicines regulatory network.
Its work was instrumental in developing and refining methods that prepared the Network for the surveillance of COVID-19 vaccines.
This work stream meets quarterly.
For more information on the activities of both work streams, refer to the EudraVigilance annual reports:
The group contains members from national competent authorities and academia leaders with expertise in signal management.
It also includes members from EMA and PRAC who have expressed an interest in participating in the group's activities.
The group may invite additional experts if required. For example, the methods work stream collaborates with external partners on specific topics, such as the World Health Organization - Uppsala Monitoring Centre (WHO-UMC).
The current members of each work stream are listed below: