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

• Үндсэн зохиолчид: Antonio Lomeli-Silva (Зохиогч), Homero Contreras-Salinas (Зохиогч), Mayra Yolanda Barajas-Virgen (Зохиогч), Maria Soledad Romero-Lopez (Зохиогч), Lourdes Yolotzin Rodríguez-Herrera (Зохиогч)
• Формат: Ном
• Хэвлэсэн: SAGE Publishing, 2024-02-01T00:00:00Z.
• Нөхцлүүд: article
• Онлайн хандалт: Connect to this object online.

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...