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Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 4 Plenary: Where Does LATAM Stand with Reliance?

Session Chair(s)

Maria Antonieta Tony Roman, MPharm

Maria Antonieta Tony Roman, MPharm

Head Regulatory Policy Emerging Markets LATAM

Novartis, Mexico

Leonardo  Semprun, PharmD

Leonardo Semprun, PharmD

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)

Maria Cristina  Mota Pina, MBA

Reflections from Industry

Maria Cristina Mota Pina, MBA

AbbVie, United States

Head, Regulatory Policy for Emerging Markets -Japan and Australia

Lawrence  Liberti, PhD, RAC

LASER II Project

Lawrence Liberti, PhD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

Fabrício  Oliveira

New Regulation for Reliance in Brazil

Fabrício Oliveira

ANVISA, Brazil

Head of Biologic Products and Advanced Therapy Medicinal Products Office

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