Q.F. Milagros Consuelo Arista Arévalo QA Specialist & Pharmacovigilance and Technovigilance Coordinator SCR Consulting Peru The outsourcing of pharmacovigilance services is an increasingly utilized strategy by pharmaceutical companies to optimize resources and ensure regulatory compliance. However, this practice must be conducted under strict quality standards and established regulations. The Good Pharmacovigilance Practices Manual (Ministerial Resolution […]
Q.F. Milagros Consuelo Arista Arévalo QA Specialist & Pharmacovigilance and Technovigilance Coordinator SCR Consulting Peru Pharmacovigilance is a fundamental pillar in drug safety, ensuring that the benefits of medications outweigh any potential risks. In this context, artificial intelligence (AI) emerges as a key tool transforming this field, enabling earlier detection of adverse effects, more efficient […]
– Las actividades de auditoría de farmacovigilancia deben verificar, con base en el examen de evidencia objetiva, que el sistema de farmacovigilancia sea adecuado, efectivo y cumpla con los criterios establecidos en las normativas nacionales. Para una auditoría exitosa, se recomienda: – Tener un correo electrónico y un número de teléfono dedicados al departamento de farmacovigilancia del establecimiento. – Informar a DIGEMID […]