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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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