Spontaneous Ae Signalling Programs

The spontaneous component of an AE signalling program is created when one or more spontaneous signalling methods are applied systematically to the AE reports for a particular product (Royall, 1971; Venulet, 1988). Spontaneous signalling programs are administered by international agencies (e.g. the World Health Organization (WHO), by national bodies (e.g. individual country regulators), by regional surveillance programs (e.g. regional phar-macovigilance units in France and Spain), and by manufacturers (e.g. manufacturer-based drug safety departments). In the past, for convenience, such signalling programs have usually been carried out as standardized regimens that were applied uncritically to multiple drugs. However, since AE signals are ultimately interpreted in the context of a particular product (Finney, 1965), spontaneous AE signalling programs are essentially product-specific (the term "product" means one or more dosage forms that are monitored together as a distinct entity). In general, the inclusion of a signalling method in a spontaneous AE signalling program should address an applicable epidemiologic, medical, or regulatory design principle and should be consistent with the International Conference on Harmonization E2A and E2C guidances (European Agency for the Evaluation of Medicinal Products, 1995, 1997; International Society for Pharmacoepi-demiology, 1996).

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