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Session 2, Tracks A, B: Good Regulatory Practices & Regulatory System Strengthening
Session Chair(s)
Maria Antonieta Tony Roman, MPharm
Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Urimara Argotti-Rodriguez, MBA
Regional Regulatory Policy LATAM Region, Global International Regulatory Policy
Productos Roche S.A. DE C.V., Mexico
This session will evaluate the importance of strong regulatory systems based on Good Regulatory Practices (GRPs) to ensure access to safe and effective medicines in Latin America. Attendees will analyze how the efficiency of regulatory pathways can be improved through clear and objective procedures, by following GRP’s, and will include case studies and takeaways to further insights.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the importance of GRPs for strengthening and improving the performance of sustainable regulatory systems
- Identify regional efforts that drive the adoption of GRPs
- Share best practices in implementing GRP’s in Latin America for drug products and medical devices
Speaker(s)
Speaker: Cammilla Horta Gomes, MA, MPharm
LATAM Regulatory Policy Lead
Roche, Brazil
Speaker: Sandra Ligia González Aguirre
Executive Secretary, Inter-American Coalition for Regulatory Convergence
Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Speaker: Jose Vicente Coto, DrMed, MEd, MPA, MPH
Subregional Advisor, Regulatory Strengthening of Medicines and Other Technologie
Pan American Health Organization (PAHO), United States
Speaker: Leonardo Dutra Rosa
Head of the International Affairs Office
ANVISA, Brazil
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