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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)
Mario Alanis, PHD
Senior Advisor , Erudee Foundation, Frpath, Mexico
Nawaf Matar Almutairi, MPHARM
Regulatory Affairs Expert , Saudi Food and Drug Authority , Saudi Arabia
Rebecca Lumsden, PHD
Head of Regulatory Science & Policy EU/AMEE, Sanofi, United Kingdom
Sandra Ligia González Aguirre
Executive Secretary, Inter-American Coalition for Regulatory Convergence, Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Maria Teresa Zelaya Lemus
Head of the Drug Registration Unit, Dirección Nacional de Medicamentos de El Salvador, El Salvador
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