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Session 6: E-Labeling and Other Digital Solutions
Session Chair(s)
Maria Cristina Mota Pina, MBA
Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
Latin America Federation of Pharmaceutical Industry (FIFARMA), United States
Leonardo 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)
A Snapshot of the Global ePI Landscape
Ronnie Harprit Mundair
Pfizer, United Kingdom
Regional Labelling Head - AfME, Canada and LATAM - Senior Director
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
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
ePI Project Spain
Elisa Sulleiro Avendaño
AEMPS, Spain
Head of the Registration Procedures Management Division
Panelist
Gustavo Mendes Lima Santos, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Herbal and Complementary Medicines Office - GMESP
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