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Virtual

Feb 22, 2021 7:00 AM - Feb 24, 2021 8:00 PM

(Eastern Standard Time)

Latin America Regulatory Conference

Session 8: Regulatory Convergence in Pandemic Situations

Session Chair(s)

Roberta  Mele Mazza, RPh, RAC

Roberta Mele Mazza, RPh, RAC

Q&RA Manager, División Diagnóstica

Productos Roche , Argentina

Maria Cristina  Mota Pina, MBA

Maria Cristina Mota Pina, MBA

Head, Regulatory Policy for Emerging Markets -Japan and Australia

AbbVie, United States

“Regulatory convergence,” represents a process whereby the regulatory requirements across countries or regions become more similar or “aligned” over time. This session aims to provide an overview of “lessons learned” during a pandemic situation and share examples of good regulatory practices for medical devices and medicines in the Latin America the region.

Learning Objective :
  • Raise the awareness on different Convergence initiatives already existing and new initiatives for medical devices and medicines
  • Understand how Regulators are working towards regulatory convergence in pandemic situations for medical devices and medicines
  • Provide an industry perspective in how regulatory convergence initiatives supports availability of medical devices and medicines in pandemic situations

Speaker(s)

Agnès  Saint-Raymond, DrMed

Speaker

Agnès Saint-Raymond, DrMed

European Medicines Agency, Netherlands

Head of Division International Affairs

Rebecca  Lumsden, PhD

Regulatory Convergence in Pandemic Situations an Industry perspective

Rebecca Lumsden, PhD

Sanofi, United Kingdom

Head of Regulatory Science & Policy EU/AMEE

Sandra Ligia González Aguirre

Regulatory Convergence in Pandemic Situations

Sandra Ligia González Aguirre

Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States

Executive Secretary, Inter-American Coalition for Regulatory Convergence

Steven  Bipes, PhD

Panelist

Steven Bipes, PhD

Advanced Medical Technology Association (AdvaMed), United States

Vice President - Global Strategy and Analysis

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