Strengthening Pharmacovigilance in Latin America: Multidisciplinary Insights from Two ISoP Latin American Chapter Symposia.

Abstract

Pharmacovigilance in Latin America has witnessed notable progress in recent years, marked by advancements in regulatory frameworks, regional cooperation, and increased academic involvement. However, heterogeneity among countries, uneven institutional development, and limited resources still hinder its full impact on public health. In this context, the Latin American Chapter of the International Society of Pharmacovigilance (ISoP LATAM) has played a key role in organizing two regional symposia: Cartagena, Colombia (2023), and Merida, Mexico (2025). Through multidisciplinary roundtables and open forums, ISoP LATAM has brought together regulators, academia, healthcare professionals, researchers, patient organizations, and industry representatives to promote dialogue, identify opportunities, and propose measures to improve pharmacovigilance in the region. Discussion included regulatory harmonization and convergence, the adoption of international standards for risk management and safety reporting, and the integration of artificial intelligence and real-world evidence into pharmacovigilance systems. Participants emphasized the importance of addressing medication errors through a Human Factors/Ergonomics approach, strengthening the monitoring and regulation of biosimilars, and creating differentiated frameworks for recognizing therapeutic failures. The expansion of pharmaceutical care and the systematic inclusion of pharmacovigilance education across the health sciences' curriculum were highlighted as priorities. The reflections from these symposia emphasize the crucial role of ISoP LATAM in providing a platform for open and multidisciplinary discussions. Shifting the focus from solely regulatory topics to a broader public health perspective and expanding the agenda to include emerging fields such as pharmacogenomics, ecopharmacovigilance, and patient engagement-while ensuring fair access to technological innovations-will be vital for enhancing drug safety in Latin America.