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

• Main Authors: Antonio Lomeli-Silva (Author), Homero Contreras-Salinas (Author), Mayra Yolanda Barajas-Virgen (Author), Maria Soledad Romero-Lopez (Author), Lourdes Yolotzin Rodríguez-Herrera (Author)
• Format: Book
• Published: SAGE Publishing, 2024-02-01T00:00:00Z.
• Subjects: article
• Online Access: 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...