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

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.

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Publication Details

Journal
Drug Safety
Published
2026-03-21
DOI
https://doi.org/10.1007/s40264-026-01662-w
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
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article

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

Mónica Tarapués, Cinthya Galicia-Quintanar, Daniela Fontana, Julia J. Segura-Uribe et al.
Drug Safety
Pharmacovigilance and Adverse Drug Reactions
article

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

Mónica Tarapués, Cinthya Galicia-Quintanar, Daniela Fontana, Julia J. Segura-Uribe, Victoria Hall-Ramírez, Maribel Salas, Gilberto Castañeda-Hernández, Carlos Aceves-González, Rosana Angélica Ramírez-Pedreros, Christian Camilo Cuello-Meza, Jessica Liliana Vargas-Neri, Angela Caro-Rojas, Josué Bautista-Arteaga, William Carreño-Quintero, Daniela Daza-Paz, Luz Dary Terán-Mercado, Diego Salas, Heyde Patricia Zuluaga-Arias, Betty Duarte, Diana María González-Achury, Diego Armando Galvis-Sánchez
article en

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.

Drug Safety
Roche (Switzerland) (CH), Bayer (United States) (US), Universidad Nacional de Córdoba (AR), Universidad de Guadalajara (MX), Centro Universitario Anglo Mexicano (MX), Universidad de Costa Rica (CR), Hospital Infantil de México Federico Gómez (MX), Universidad Enrique Díaz de León (MX), Hospital Español (MX), Facultad Latinoamericana de Ciencias Costa Rica (CR), Aurobindo Pharma (United States) (US), Universidad Internacional del Ecuador (EC), Secretaría de Salud de Bogotá (CO), Fresenius Kabi (United States) (US), Colombian Association of Surgery (CO), Universidad Americana (CR), Instituto Politécnico Nacional (MX), Cordoba University (US), University of Pennsylvania (US), Fresenius Kabi (Czechia) (CZ), Universidad Nacional Autónoma de México (MX)
Partnerships for the goals
Openalex Percentile: Top 12%
Pharmacovigilance and Adverse Drug Reactions
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