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5th Operationalize: Expanded Access Programs Summit - 2025
Sharing Case Studies in Navigating Complex Regulatory & Operational Hurdles to Operate Successful Early Access, Expanded Access, Managed Access & Post-Trial Access Programs. 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.
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!
The 5th Operationalize: Expanded Access Programs Summit continues to be the premier event for connecting expanded access professionals with their industry peers to share proven strategies for overcoming operational and regulatory barriers, ensuring access to life-changing therapies outside traditional clinical trials. Featuring deep-dive discussions and actionable case studies, the summit addresses global regulatory differences, best practices for transitioning patients to commercial programs, and how to leverage data to support regulatory filings, clinical trials, and therapeutic development. This is the must-attend event for experts aiming to elevate their Expanded Access Programs in 2025 and beyond.
In March, join your peers at this essential gathering, where the brightest minds in Expanded Access from companies like Novartis, Pfizer, BMS, Biogen, Ascendis, and others will converge. This collaborative, non-competitive event is designed to equip you with the knowledge and tools needed to bridge the gap between cutting-edge clinical research and the patients who need it most.
Participate in an interactive, two-track workshop day, offering actionable insights for the entire Expanded Access community, regardless of experience level. Workshops are hosted by Daiichii Sankyo, Blueprint Medicines, Gilead Sciences, Pfizer, BeiGene, Takeda, and EMD Serono.
Turbocharge your understanding of country-specific regulatory requirements to successfully run compliant global Access Programs, with expert insights from EMD Serono, Shionogi, Novartis, and The Max Foundation.
Gain insights into the operational challenges of running Access Programs in low-to-middle-income countries, ensuring equitable patient access, with guidance from GARDaccess.
Navigate the regulatory complexities of transitioning patients from free-of-charge to commercial programs, ensuring sustainable continuity of care, with insights from Blueprint Medicines.
Explore an innovative funding model that generates actionable insights, supplements clinical trial data, and informs regulatory decisions, led by Biomed Valley Discoveries.
