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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
Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Duglas Rodriguez Calderon, MSc
Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence
Roche, Panama
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)
Regional Approach for the Strengthening of Medical Devices Regulation
Alexandre Lemgruber, MSc
Pan American Health Organization (PAHO), United States
Regional Advisor, Health Technologies
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
Speaker
Augusto Geyer, MSc
ANVISA, Brazil
Head of Medical Devices Office
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