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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.
From Community to Region: Strengthening Latin American Regulatory Pathways for Decentralized Clinical Trials
Nikki Chen, Eli Lilly and Company
Adriane Alves de Oliveira, ANVISA
Mónica Belisa Carrascal Rodríguez, Center for Medical Care and Research (CAIMED)
Laura Traversi, ANMAT Ministry of Health, Argentina
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)
Enabling Next-Generation Trials – Regulatory Alignment to Accelerate Decentralized and Innovative Research in Latin America
Nikki Chen, PharmD
Manager, Global Regulatory Policy & Strategy, Eli Lilly and Company, United States
Advancing Clinical Trials in Latin America – Regulatory Alignment for Decentralized and Innovative Study Designs: Approach of the Argentine Regulatory Agency
Laura Traversi, MD
Head of Clinical Trials Department, ANMAT Ministry of Health, Argentina
Advancing Clinical Trials in Latin America – Regulatory Alignment for Decentralized and Innovative Study Designs
Adriane Alves de Oliveira
Deputy Head, Clinical Trials Office, ANVISA, Brazil
Speaker
Monica Belisa Carrascal Rodríguez
Director of Clinical Operations, CAIMED International Sites, Center for Medical Care and Research (CAIMED), Mexico
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