Sharing Case Studies in Navigating Complex Regulatory & Operational Hurdles to Operate Successful Early Access, Expanded Access, Managed Access & Post-Trial Access Programs
This event has now run. Thank you to our speakers, sponsors, and delegates who joined us in Boston for the Summit!
If you are interested in the 2026 event, please get in touch at
info@hansonwade.com
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.
What was in store at the 5th Operationalize: Expanded Access Programs Summit 2025?
Over 120 thought leaders from Access, Medical Affairs, Clinical Operations, and Clinical Supply joined 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 the 2025 Summit, attendees gained 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. They also explored 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!
Snapshot of the 2025 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:
