National Costume: Expanded Access Programs From Regulatory Concept to Execution-Ready Strategy

Tuesday, January 27, 2026

Expanded Access Programs From Regulatory Concept to Execution-Ready Strategy

Greetings!

Expanded Access Programs are becoming an increasingly important part of drug development when patients cannot wait for standard clinical trial timelines or commercial availability. While these programs can provide critical access to investigational therapies, many sponsors struggle to design EAPs that are regulator ready, operationally feasible for clinical sites, aligned with pharmacovigilance expectations, and consistent with long-term development strategy.

This workshop provides a practical, sponsor focused guide to building an Expanded Access Program from end to end. Participants will learn how to define program intent, select the appropriate program model, develop an execution-ready protocol structure, establish a realistic minimal dataset, and plan cross-country implementation using a clear and reusable framework that balances compliance with feasibility.

The session covers early access pathways such as EAPs, post-trial access, and open label extensions, along with the trial-first principle, access versus study-style models, protocol design essentials, safety oversight, data strategy, and operational planning. Attendees will gain practical tools to avoid common regulatory and execution pitfalls while creating programs that support both patient access and development goals.

This workshop is designed for professionals involved in clinical development and regulatory execution, including medical writers, regulatory affairs teams, clinical operations leads, pharmacovigilance professionals, medical affairs staff, CRO project teams, quality and compliance professionals, and investigators supporting early access requests and reporting.

The session is led by Dr. Tigran Uzunyan, a physician and clinical pharmacologist with over 18 years of experience across academia, pharmaceutical development, regulatory strategy, and clinical research. His background spans early phase and late phase clinical studies, multi-jurisdictional regulatory work, and real-world research programs, bringing a practical and lifecycle-focused perspective to Expanded Access planning and execution.

We look forward to welcoming you to this in-depth and applied session on building regulator-ready Expanded Access Programs.