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Session 8, Track A: Smarter Regulation Through Reliance - Lessons, Evidence, and Opportunities for LatAm Alignment
Session Chair(s)
Daniela Bravo, MBA
Regulatory Policy and Intelligence Latam Associate Director, AbbVie, Brazil
Vesa Vuniqi, MS
International Relations Specialist, Latin America Office, FDA, United States
Regulatory reliance continues to evolve as a key strategy to enhance efficiency, reduce duplication, and accelerate patient access to medical products globally. This session will explore how reliance is being operationalized across regions for different regulatory processes and products. It will then highlight real-world applications from regulators, followed by insights from recent developments on this matter. The session aims to provide a comprehensive view of reliance, from global frameworks to implementation and evidence, highlighting challenges, successes, and opportunities for advancing reliance practices in Latin America.
Learning Objective : At the conclusion of this session, participants should be able to - Explain key principles of the reliance framework for medical devices
- Analyze how regulators apply reliance in practice
- Identify gaps and opportunities of the implementation of reliance
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