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Session 4 Plenary: Where Does LATAM Stand with Reliance?
Session Chair(s)
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
Leonardo Semprun, PHARMD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
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
Head of Intercontinental Regulatory Policy & Intelligence, AbbVie, United States
LASER II Project
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
New Regulation for Reliance in Brazil
Head of Biologic Products and Advanced Therapy Medicinal Products Office, ANVISA, Brazil
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