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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
Roche, Brazil
LATAM Regulatory Policy Lead
Speaker
Sandra Ligia González Aguirre
Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Executive Secretary, Inter-American Coalition for Regulatory Convergence
Speaker
Jose Vicente Coto, DrMed, MEd, MPA, MPH
Pan American Health Organization (PAHO), United States
Subregional Advisor, Regulatory Strengthening of Medicines and Other Technologie
Speaker
Leonardo Dutra Rosa
ANVISA, Brazil
Head of the International Affairs Office
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