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Session 4 Plenary: Where Does LATAM Stand with Reliance?
Session Chair(s)
Maria Antonieta Tony Roman, MPharm
Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Leonardo Semprun, RPh
Global Regulatory Policy Lead-LatAm
MSD, Panama
Reliance is applicable to the different stages of the lifecycle of products and plays an important role by generating efficiencies to regulatory systems. This session will bring together regional regulators, multiregional organizations, and industry representatives to jointly discuss ongoing efforts to drive regulatory reliance aiming to use regulatory resources more efficiently by helping to reduce workload so that resources can be prioritized elsewhere in all regulatory systems, regardless of their size and/or existing resources. Despite recent progress made by regulators in the region in adopting this mechanism, there are still opportunities for further strengthening this practice.
Learning Objective : At the conclusion of this session, participants should be able to:
- Share trends and case of studies on effective reliance practices in the region
- Discuss major remaining obstacles and recommend a path forward to expand the use of reliance
- Assess challenges and lessons learned about reliance in the region
Speaker(s)
Reflections from Industry
Maria Cristina Mota Pina, MBA
Latin America Federation of Pharmaceutical Industry (FIFARMA), United States
Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
LASER II Project
Lawrence Liberti, PhD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science
New Regulation for Reliance in Brazil
Fabrício Oliveira
ANVISA, Brazil
Head of Biologic Products and Advanced Therapy Medicinal Products Office