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Session 3, Track A: From Principles to Impact: The Benefits of Implementing Good Regulatory Practices in Latin America
Session Chair(s)
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Diego Alexander Salas, LLM
Regulatory Affairs Director, Federación Latinoamericana de la Industria Farmacéutica, A.C., Mexico
This session will explore the implementation and impact of Good Regulatory Practices (GRPs) in Latin America, highlighting institutional experiences from ANMAT and ANVISA. Through real-world examples and regional insights, speakers will examine how GRPs—such as transparency, stakeholder engagement, evidence-based decision-making, and regulatory impact assessments—are strengthening regulatory systems and advancing public health objectives. The session will also feature key findings from the Latin American Regulatory Practices Observatory, a study conducted by INNOS, offering data-driven insights into the progress and gaps in GRP adoption across the region. Finally, panelists will reflect on challenges and opportunities for embedding GRPs across the regulatory lifecycle and promoting convergence.
Learning Objective : - Define key elements of Good Regulatory Practices (GRPs)
- Identify examples of GRP implementation in Latin American regulatory authorities
- Apply GRP principles to strengthen processes within their own regulatory frameworks
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Discuss methods for integrating impact assessments and public consultations in regulatory decision-making
Speaker(s)
Diego Alexander Salas, LLM
Regulatory Affairs Director, Federación Latinoamericana de la Industria Farmacéutica, A.C., Mexico
Good Regulatory Practices in Medical Device Regulation: What Are They, Why Do They Matter, and How Do They Work?
Estefania Mariel Gerez, MPA
Professional from the National Institute of Drugs, ANMAT Ministry of Health, Argentina
From Principles to Impact: The Benefits of Implementing Good Regulatory Practices in Latin America
Carlos Felipe Escobar Roa, MD
Director, Institute for Health Foresight and Innovation (INNOS), Colombia
How Are We Regulating? Insights from the Latin American Regulatory Practices Observatory
Thalita Antony de Souza Lima, MPA
Assessor of the Cabinet of the Director President, Brazilian Health Regulatory Agency (ANVISA), Brazil
The Role of Good Regulatory Practices (GRPs) in Supporting Better Regulatory Outcomes: The ANVISA Experience
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