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Spontaneous reporting

    Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is not solicited). Stimulated reporting Reporting of an AE case triggered by a specific occurrence such as:
    • A direct healthcare professional communication (DHPC)
    • A publication in the press
    • Survey of healthcare professionals by company representatives
    • Invitation from patient organizations to their members
    • Reporting made during early phase post-marketing vigilance (EPPV)
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