The International Working Group on Signal Detection and Management in Pharmacovigilance
The International Working Group (IWG) on Signal Detection and Management in Pharmacovigilance was launched in March 2019. Experts from over 20 organisations in the pharma industry and academia have joined the IWG in order to examine aspects of signal detection and signal management.
Signal Detection and Management are key steps in the pharmacovigilance process. While the CIOMS Working Group Report on Signal Detection was published in 2010, a lot has happened in this field since then. IWG members include international experts in signal detection who will examine the science, define the needs and propose ideas and guidance for the future.
The IWG on Signal Detection and Management in Pharmacovigilance is managed under the auspices of the DSRU Centre for Methods and Evidence in Pharmacovigilance (MEP), which was created in 2018 to undertake methodological work to improve and enhance pharmacovigilance.
The IWG is expected to run for 3 years.
The mission of the IWG is to assess the impact of new developments in biomedical sciences on signal detection and management in pharmacovigilance, aiming to improve its efficiency and protect public health.
Strategic objectives of the IWG
- To examine the impact and possible application of recent applications in biomedical sciences to the process and outcomes of signal detection and management. Such recent developments include:
- the availability of new data sources including big data (both scientific, e.g. biobanks and general, for example user generated content such as social media and internet search logs),
- the application in the biomedical field of Artificial Intelligence, including Machine Learning,
- the impact of accelerating advances in genetics and network/systems biology on signal detection and management of adverse drug reactions.
- To assess and usefully extend what is known about the possible benefits of the use of other data sources (including observational data) to complement spontaneous reporting of suspected adverse drug reactions in signal detection and management. Also to examine the approaches and possible benefits of the application of epidemiological methods to this field.
- To review the current methods for signal detection and management, particularly to further quantify their contributions and assess their shortcomings in the timely identification, processing and delivery of Pharmacovigilance signals that impact on public health. Also, examine the limitations of the existing methods to detect signals for newly marketed medicines and medicines with limited usage, including orphan drugs. To recommend further development and improvement based on the IWG’s evaluation.
Eleven subgroups will be established in order to address each of the key issues. Each subgroup will contribute a chapter to a final report, which will be published in 2022.
Watch this short video for further information about the IWG on Signal Detection and Management in Pharmacovigilance: