Sharing Case Studies in Navigating Complex Regulatory & Operational Hurdles to Operate Successful Early Access, Expanded Access, Managed Access & Post-Trial Access Programs
The 5th Operationalize: Expanded Access Programs Summit
Expanded Access Programs (EAPs) are increasingly recognized as an ethical imperative in modern healthcare. More companies are opening EAPs to provide critical therapies to patients who would otherwise lack access. However, challenges persist, especially when navigating the complex regulatory landscape of global programs. From country-specific regulations to post-trial access, managing global supply chains, importation, licensing, and labeling standards remains a critical focus for ensuring patients worldwide receive the treatments they need.
Welcome to, or welcome back to, the 5th Operationalize: Expanded Access Programs Summit 2025!
Join over 120 thought leaders from Access, Medical Affairs, Clinical Operations, and Clinical Supply for an unparalleled opportunity to network, exchange insights, and explore innovative strategies for overcoming the regulatory and operational hurdles that complicate global access to life-saving therapies.
At this year’s summit, you'll gain actionable insights on successfully planning and executing Post-Trial Access Programs, navigating the regulatory landscapes of the US, LATAM, Europe, and South & East Asia, and developing compliant, effective global access strategies. You’ll also explore best practices for creating exit plans and transition strategies that address hurdles in reimbursement, off-request processes, and country-specific regulations—plus so much more!
ACCESS THE AGENDA
Snapshot of Your Expert Speaker Faculty:
Amber Bifolck Fisher
Senior Clinical Research Manager, Expanded Access & Investigator Initiated Study Programs
Kura Oncology
Joseph Muenzer
Professor - Pediatric & Stakeholder Engagement University of North Carolina
Chapel Hill
Previously Attending Companies:
Our 2025 Partners:
Other Events in the Series:
