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Session 1: Setting the Scene
Session Chair(s)
Maria Paula Bautista Acelas, MSc
Scientific Program Manager, Research Partnerships, DIA, United States
This opening session will set the foundation for the workshop by providing an overview of the current regulatory reliance landscape across Latin America. Participants will gain insights into existing reliance pathways, practical examples of implementation, and the opportunities and challenges shaping their adoption across the region. Building on this context, the first part of the workshop will also explore practical considerations for strengthening reliance through greater information sharing, transparency, and collaboration between regulators and industry, including perspectives on reliance-based dossier submissions and opportunities to improve the predictability of regulatory processes.
Speaker(s)
The Current Reliance Landscape in Latin America
Juan Lara
Senior Research Analyst, Centre For Innovation In Regulatory Science (CIRS), Mexico
Practical Considerations for Reliance Implementation: Enhancing Information Sharing and Transparency
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
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