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Session 2: Reliance and Regulatory System Strengthening
Session Chair(s)
Cammilla Horta Gomes, MA, MPharm
Latam Regulatory Policy Lead
Roche, Brazil
Roberta Mele Mazza, RPh, RAC
Q&RA Manager, División Diagnóstica
Productos Roche , Argentina
As an approach that supports the best use of available resources and expertise, reliance plays an important role in facilitating timely access to safe, effective and quality-assured medicines and medical devices, as well as in helping regulatory preparedness and response, particularly in context of public health emergencies.
This session will focus on discussing the role of good reliance practices in regulatory decision-making, as well as other tools for regulatory systems strengthening that increase the efficiency of regulators, producing better public health outcomes. It will present the most recent global developments and resources to support regulators, as well as updated information about the global and regional regulatory scenario and practical considerations that can lead to more consistent regulatory processes.
Learning Objective : At the conclusion of this session, participants should be able to:
- Be familiar with the most up-to-date resources that support regulatory systems strengthening and the adoption of good reliance practices
- Value the benefits of reliance approaches in regulatory decision making, including in the context of public health emergencies
- Understand the current regional landscape and identify opportunities to improve regulatory efficiencies
Speaker(s)
Regulatory Systems Strengthening – Global Update
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Results of CIRS Reliance Study for Latin America
Lawrence Liberti, PhD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science
Strengthening Regulatory Systems: a consolidated industry perspective
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
Panelist
Rebecca Lumsden, PhD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
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