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 […]
Q.F. Ronald Erik Quiñonez Dextre Regulatory Affairs and Pharmacovigilance Analyst SCR Consulting Peru As part of the development of the pharmacovigilance system in Peru, since the publication of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products (Supreme Decree No. 016-2011-SA), the preparation and presentation of the […]