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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 of Intercontinental Regulatory Policy & Intelligence, 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
Head of Division International Affairs, European Medicines Agency, Netherlands
Speaker
Rebecca Lumsden, PhD
Head of Regulatory Science & Policy EU/AMEE, Sanofi, United Kingdom
Regulatory Convergence in Pandemic Situations an Industry perspective
Sandra Ligia González Aguirre
Executive Secretary, Inter-American Coalition for Regulatory Convergence, Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Regulatory Convergence in Pandemic Situations
Steven Bipes, PhD
Vice President - Global Strategy and Analysis, Advanced Medical Technology Association (AdvaMed), United States
Panelist