Work Package 4 focused on national schemes for the spontaneous reporting of adverse drug reactions (ADRs) and aimed to provide National Competent Authorities (NCAs) with a full understanding of and best practice in systems for collecting ADRs. Information was gathered from European NCAs to understand their national pharmacovigilance IT system capabilities as well as implementation of patient reporting, types and reporting forms developed, and electronic reporting developments including those from clinical healthcare systems. This information was used to create a toolkit for raising awareness of ADR reporting systems, best practice guidelines, and other learning materials which supported delivery of a training course for NCAs. SCOPE produced an animation and three infographics (1, 2, 3) to raise awareness of national ADR reporting systems.
Work Package 4 – ADR Collection outputs:
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