Latin America Annual Meeting

Artificial intelligence is reshaping the regulatory and pharmacovigilance ecosystem, transforming how agencies review dossiers, how sponsors generate evidence, and how safety signals are detected across the product lifecycle. As global frameworks mature—from the FDA's January 2025 draft guidance “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products” and complementary documents on AI in drug manufacturing and AI/ML for drug development, to the CIOMS Working Group XIV report on AI in pharmacovigilance—Latin American regulators and industry face a defining question: how to adopt AI responsibly while strengthening regional regulatory systems, ensuring patient safety, and enabling timely access to innovation. This closing plenary brings together regulators, international organizations, and industry leaders for a forward-looking dialogue on AI deployment across the medicines lifecycle. The conversation will open with the regulator's perspective on AI inside the agency, anchored by FDA's risk-based credibility assessment framework and complemented by digitalization initiatives underway across Latin American agencies. Industry will then share its experience of operationalizing AI throughout the lifecycle—from drug discovery and clinical trial optimization to regulatory operations and manufacturing—offering a practical view of how global tools are validated and deployed in regional submissions. Through a pharmacovigilance lens, the session will translate the CIOMS Working Group XIV principles of validity and robustness, fairness and equity, and governance and accountability into concrete implications for marketing authorization holders in LatAm across ICSR processing, signal detection, literature monitoring, and real-world data analysis, with particular attention to ANVISA's evolving expectations. By bridging regulatory, safety, and industry perspectives, this plenary equips participants with a strategic framework to engage with AI as both a transformative opportunity and a governance challenge.