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Latin America Regulatory Conference


Session 2: Reliance and Regulatory System Strengthening

Session Chair(s)

Cammilla  Horta Gomes, MA

Cammilla Horta Gomes, MA

  • LATAM Regulatory Policy Lead
  • Roche, Brazil
Roberta  Mele Mazza, RPh, RAC

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)

Samvel  Azatyan, MD, PhD

Regulatory Systems Strengthening – Global Update

Samvel Azatyan, MD, PhD

  • Team Lead, Regulatory Convergence and Networks (RCN/REG)
  • World Health Organization (WHO), Switzerland
Lawrence  Liberti, PhD, RPh, RAC

Results of CIRS Reliance Study for Latin America

Lawrence Liberti, PhD, RPh, RAC

  • Adjunct Assistant Professor
  • Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States
Sandra  González

Strengthening Regulatory Systems: a consolidated industry perspective

Sandra González

  • Executive Secretary,Inter-American Coalition for Regulatory Convergence
  • Advanced Medical Technology Association (AdvaMed), United States
Steven  Bipes

Panelist

Steven Bipes

  • Vice President - Global Strategy and Analysis
  • Advanced Medical Technology Association (AdvaMed), United States
Rebecca  Lumsden, PhD

Panelist

Rebecca Lumsden, PhD

  • Director, Regulatory Policy and Intelligence
  • Pfizer Inc, United Kingdom

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