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Session 8: Regulatory Convergence in Pandemic Situations
Session Chair(s)
Roberta Mele Mazza, RPH, RAC
Q&RA Manager, División Diagnóstica
Productos Roche , Argentina
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)
Speaker
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Regulatory Convergence in Pandemic Situations an Industry perspective
Rebecca Lumsden, PHD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
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
Panelist
Steven Bipes, PHD
Advanced Medical Technology Association (AdvaMed), United States
Vice President - Global Strategy and Analysis