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Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation

To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible thro...

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Главные авторы:	Antonio Lomeli-Silva (Автор), Homero Contreras-Salinas (Автор), Mayra Yolanda Barajas-Virgen (Автор), Maria Soledad Romero-Lopez (Автор), Lourdes Yolotzin Rodríguez-Herrera (Автор)
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Опубликовано:	SAGE Publishing, 2024-02-01T00:00:00Z.
Предметы:	article
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