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Session 6: E-Labeling and Other Digital Solutions
Session Chair(s)
Maria Cristina Mota Pina, MBA
Head of Intercontinental Regulatory Policy & Intelligence, AbbVie, United States
Leonardo Semprun, PHARMD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
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 Mundair
Regional Labelling Head - Canada and LATAM - Senior Director, Pfizer, United Kingdom
Rutendo Kuwana, RPH
Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
Bruno Di Martino, MBA, PMP
Global Regulatory Strategy, Immunology, Abbvie Inc., United States
Elisa Sulleiro Avendaño
Head of the Registration Procedures Management Division, AEMPS, Spain
Gustavo Mendes Lima Santos, MPHARM
Herbal and Complementary Medicines Office - GMESP, Brazilian Health Regulatory Agency (ANVISA), Brazil
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