Expanded Access 101: Understanding the Basics to Plan for & Manage a First Rate Expanded Access Program
Time: 9:00 am
day: Pre-Conference Workshop Day
Details:
For many biopharma companies, there is limited internal expertise related to expanded access, which can impact operational efficiency and regulatory compliance. Designed for an audience less experienced in expanded access, this workshop will address considerations for planning and executing Expanded Access Programs by identifying strategic approaches and anticipating common challenges through a mix of practical case studies and solution-driven discussions.
Key Takeaways:
- Learn the Fundamentals: Gain a clear understanding of what Expanded Access Programs are, including key regulatory requirements, eligibility criteria, and distinctions from clinical trials
- Plan with Confidence: Discover best practices for early planning and crossfunctional coordination to design and implement a successful Expanded Access Program
- Manage with Excellence: Explore real-world case examples and practical strategies to ensure compliant, patient-focused execution and stakeholder engagement throughout the program lifecycle
