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Session 6, Track A: Enabling Next Generation Trials - Regulatory Alignment to Accelerate Decentralized and Innovative Research in LatAm
Session Chair(s)
Priscila De Lara Fagundes Esteves, RPH
Director Regulatory Affairs , PPD Clinical Research Services, Thermo Fisher Scientific, Brazil
Monica Lizano, MD, MBA
Global Director, Clinical Quality Management, Merck Chile, Chile
This session will explore how evolving regulatory requirements across Latin America—spanning remote oversight, digital consent, data validation, and community-based site operations—are shaping decentralized clinical trials and innovative study designs, including adaptive, hybrid, and digitally enabled models. While variability across countries can challenge scalability and limit patient access, increased cross-country collaboration offers an opportunity to generate locally relevant evidence and accelerate innovation. Experts will discuss how greater regional alignment, supported by global frameworks such as ICH E6(R3), can enable more consistent approaches to quality, monitoring, and oversight.
Learning Objective : At the conclusion of this session, participants should be able to - Identify regulatory differences across Latin America impacting decentralized and community-based trial feasibility
- Assess opportunities within regional regulatory environments to support more inclusive and innovative clinical research
- Apply strategies for multi-country collaboration, capacity building, and partnerships to advance harmonized trial approaches
Speaker(s)
Nikki Chen, PHARMD
Manager, Global Regulatory Policy & Strategy, Eli Lilly and Company, United States
From Community to Region: Strengthening Latin American Regulatory Pathways for Decentralized Clinical Trials
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