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Session 9, Track A: Building a Connected Regulatory Future: Leveraging Structured Data, Cloud Ecosystems, and ePI Across Latin America
Session Chair(s)
Cesar Vinces
Advisor, Regulatory Innovation, Nuvara, United States
Monica Lizano, MD, MBA
Global Director, Clinical Quality Management, Merck Chile, Chile
The regulatory landscape in Latin America is at an inflection point, with emerging digital models beginning to reshape how submissions are prepared, reviewed, and delivered across the world. This session examines four interconnected dimensions of that evolution: the advancement of eCTD, the adoption of cloud ecosystems to operationalize collaborative regulatory pathways, structured data frameworks such as ICH M4Q and M11 anchored in FHIR and IDMP standards, and the emergence of electronic product information for the digital delivery of approved prescribing information to patients, healthcare professionals, and regulators. Structured as a panel discussion, each speaker will deliver a focused presentation on their topic followed by a moderated discussion that explores the intersections across all four dimensions, offering attendees both depth and breadth across this rapidly evolving landscape. Attendees will leave better equipped to assess how structured data, cloud submissions, and ePI can collectively strengthen regulatory digital capabilities and position the region for a more interoperable and interconnected future.
Learning Objective : - Recognize the current state of eCTD and cloud-based submission adoption in Latin America and analyze key opportunities and barriers to implementation across the region
- Identify structured data frameworks within collaborative cloud ecosystems to evaluate how data exchange and interoperability can strengthen regulatory submissions
- Differentiate the global ePI landscape and evaluate actionable steps for advancing electronic product information across LatAm 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
Vada Perkins, MS
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
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