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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 5 Plenary: Building Strong Regulatory Systems for Medical Devices and In Vitro Diagnostics: Foundational Principles, Current Efforts and Opportunities

Session Chair(s)

Viktoria  Magyar, LLM, MSc

Viktoria Magyar, LLM, MSc

Doctoral Student, Department of Regulatory and Quality Sciences

USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Duglas  Rodriguez Calderon, MSc

Duglas Rodriguez Calderon, MSc

Global Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence

Roche, United States

This session will explore the foundational principles for the development of robust, fit-for-purpose regulatory frameworks for medical devices and in vitro diagnostics (IVDs) and will provide an overview of the current regulatory initiatives, efforts and challenges for the strengthening of the regulatory systems due to emerging technologies and innovation. This session will include perspectives from the different actors in the MedTech Sector to provide a comprehensive discussion on the pathways and alternatives on strengthening the regulatory capacity of medical devices and IVDs in the Latin American region and how will benefit patient access to these innovative medical products.

Learning Objective :
  • Recognize the foundational principles required for the development of proper, robust regulatory framework considering the current scenario in LATAM
  • Follow the implementation of strategies and plans to strengthen the regulatory systems and guarantee access to medical devices, IVDs and other related medical products
  • Identify opportunities to contribute towards regulatory system strengthening and optimization

Speaker(s)

Alexandre  Lemgruber, MSc

Regional Approach for the Strengthening of Medical Devices Regulation

Alexandre Lemgruber, MSc

Pan American Health Organization (PAHO), United States

Regional Advisor, Health Technologies

Tammy  Steuerwald, JD

Building Strong Regulatory Systems for Medical Devices and In Vitro Diagnostics: Foundational Principles, Current Efforts and Opportunities

Tammy Steuerwald, JD

Roche Diagnostics, United States

Head of Regulatory Policy for Foundational Principles and Supranational Organiza

Augusto  Bencke Geyer, MSc

Speaker

Augusto Bencke Geyer, MSc

ANVISA, Brazil

Health Regulatory Expert, International Affairs Office

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