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Virtual

Mar 14, 2022 10:00 AM - Mar 16, 2022 3:15 PM

(US Eastern Standard Time)

Latin America Regulatory Conference

DIA Your Way! Join us virtually from the comfort of your home/office March 14-16 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 6: E-Labeling and Other Digital Solutions

Session Chair(s)

Maria Cristina  Mota Pina, MBA

Maria Cristina Mota Pina, MBA

Head, Regulatory Policy for Emerging Markets -Japan and Australia

AbbVie, United States

Leonardo Semprun Semprun, RPh

Leonardo Semprun Semprun, RPh

Global Regulatory Policy Lead-LatAm

MSD, Panama

Nowadays, and especially after the pandemic, it is clear how the world is connected as new tools and technologies emerged to enable patients have access to quality and safe products in an expedited manner. E-labeling and traceability tools are central to support this endeavor. These tools allow that the information needed is accessible to relevant stakeholders (health care professionals, patients, health authorities and industry) in a timely way, allowing them to make sound decisions that leads to better post-marketing surveillance. In this session the attendees will be able to learn how the evolution of e-Labeling and traceability were catalyzed by the COVID-19 pandemic and how these lessons are applicable to the Latin America region.

Learning Objective :
  • Describe traceability and labeling information importance, the synergies supporting regulatory system strengthening and post-marketing surveillance
  • Explain how implementing these initiatives contributes to avoidance of supply chain issues during critical situations permitting supply chain flexibilities
  • Discuss what the current landscape and trends and the benefits of a common and harmonized approach

Speaker(s)

Ronnie Harprit Mundair

A Snapshot of the Global ePI Landscape

Ronnie Harprit Mundair

Pfizer, United Kingdom

Regional Labelling Head - AfME, Canada and LATAM - Senior Director

Rutendo  Kuwana, RPh

Scope for e-PI in Low to Middle Income Countries

Rutendo Kuwana, RPh

World Health Organization (WHO), Switzerland

Team Lead, Incidents and Substandard/Falsified Medical Products

Bruno  Di Martino, MBA, PMP

Considerations for Implementation and Adoption of Digital Labels Across Latin America

Bruno Di Martino, MBA, PMP

Abbvie Inc., United States

Head, Latin America Regulatory Affairs

Elisa  Sulleiro Avendaño

ePI Project Spain

Elisa Sulleiro Avendaño

AEMPS, Spain

Head of the Registration Procedures Management Division

Gustavo  Mendes Lima Santos, MPharm

Panelist

Gustavo Mendes Lima Santos, MPharm

Brazilian Health Regulatory Agency (ANVISA), Brazil

Herbal and Complementary Medicines Office - GMESP

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