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Session 2: Reliance and Good Regulatory Practices
Session Chair(s)
Susan Zavala Coloma, MS, RPh
Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
DIGEMID, Peru
Cammilla Horta Gomes, MA, MPharm
LATAM Regulatory Policy Lead
Roche, Brazil
Regulatory frameworks and processes that achieve public health objectives, increasingly depend on promoting collaboration, networking, dialogue, trust, and interdependence. This session will gather experts - from international organizations, health authorities, research institutions and industry - to explore international best practices that support transparent, predictable, and consistent regulatory activity, where individual players focus their efforts on where they can add the best value.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify main concepts and uses of Good Regulatory Practices and Good Reliance Practices
- Assess relevance and application for strengthening regulatory systems in Latin America and the Caribbean
- Distinguish current challenges and opportunities in achieving more efficient regulatory oversight in the region
Speaker(s)
Latin American Systems to Enable Reliance: Best Practices and Recommendations
Mario Alanis, PhD
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Senior Advisor
Experience with Abridge and Verification Reliance Pathways in Saudi Arabia
Nawaf Matar Almutairi, MPharm
Saudi Food and Drug Authority , Saudi Arabia
Regulatory Affairs Expert
Good Regulatory Practices as a Basis for Mature Regulatory Systems
Rebecca Lumsden, PhD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
Panelist
Sandra Ligia González Aguirre
Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Executive Secretary, Inter-American Coalition for Regulatory Convergence
Panelist
Maria Teresa Zelaya Lemus
Dirección Nacional de Medicamentos de El Salvador, El Salvador
Head of the Drug Registration Unit
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