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Session 9, Track A: The Future of LATAM Submissions - Structured Data, Cloud Technology, and ePI as Emerging Digital Models for the Region
Session Chair(s)
Cesar Vinces
Advisor, Regulatory Innovation, Nuvara, United States
Monica Lizano, MD, MBA
Global Director, Clinical Quality Management, Merck Chile, Chile
Session 9, Track A: The Future of LATAM Submissions - Structured Data, Cloud Technology, and ePI as Emerging Digital Models for the Region
Learning Objective : After this session, participants will be able to: 1. Describe the current global ePI landscape including key pilot programs and regulatory frameworks across Europe, Asia, and the Americas. 2. Identify the benefits and risks of ePI for patients, HCPs, and regulators in the LATAM context 3. Apply FIFARMA’s stepwise roadmap to assess ePI readiness and plan implementation in their markets.
Speaker(s)
Michael Mayrosh, PHARMD
Associate Director Global Regulatory Policy and Strategy, Eli Lilly and Company, United States
From Paper to Pixel: The Global ePI Landscape, Pilot Programs, and a Roadmap for Latin America
Representative Invited
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Shaping the Future of Regulatory Submissions Through Collaborative Cloud Ecosystems and Structured Data