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 […]
– Pharmacovigilance audit activities should verify, based on the examination of objective evidence, that the pharmacovigilance system is adequate, effective, and complies with the criteria established in national regulations. For a successful audit, it is recommended to: – Have an email and phone number dedicated to the pharmacovigilance department of the establishment. – Inform DIGEMID […]