Reliance Workshop: September 9
Meeting: September 9 – September 11

Across Latin America, stakeholders involved in the regulation and development of pharmaceuticals and medicines continue to explore and implement reliance approaches as a way to strengthen regulatory decision-making, optimize limited resources, reduce duplication of effort, and facilitate timely access to quality, safe, and effective medicines. While many agencies have introduced reliance pathways or referenced the work of trusted authorities, the operationalization of reliance in practice remains uneven across the region. Differences in regulatory frameworks, access to assessment reports, internal capacity, and levels of stakeholder engagement often create challenges when applying reliance consistently. As a result, there is increasing interest among regulators, the pharmaceutical industry, and other healthcare stakeholders to better understand how reliance can be implemented in practical, transparent, and sustainable ways.

This workshop will provide a neutral and educational forum for regulators and industry representatives to exchange perspectives on the current reliance landscape in Latin America and explore practical approaches for implementation. Rather than focusing on theoretical concepts, the discussion will emphasize real-world experiences, operational challenges, and opportunities to strengthen collaboration. Participants will hear examples from established international reliance models, including stakeholder engagement platforms and collaborative initiatives, and will discuss how similar approaches could inform regional efforts.

A key objective of the workshop is to identify practical steps that can support the effective use of reliance across the region, including improving transparency around reference authority outputs, strengthening technical capacity within regulatory agencies, and facilitating constructive dialogue between regulators and industry. Through a combination of expert presentations and interactive breakout discussions, participants will discuss opportunities to map current reliance pathways, identify training needs, and discuss mechanisms that may support greater regional collaboration and knowledge sharing.

By bringing together participants from regulatory agencies, industry, and other stakeholders, this reliance pre-conference workshop aims to create a collaborative environment where participants can openly discuss challenges, share best practices, and identify areas for future capacity building and dialogue. The insights generated during the workshop may help inform future educational initiatives, collaborative forums, and practical resources that support the continued evolution of reliance approaches in Latin America, while recognizing that there is no single model for implementation and that approaches should remain adaptable to different national regulatory contexts and capacities.