Pre-Conference Workshop Day
Tuesday, July 29
8:30 am Registration & Coffee
WORKSHOP A | 9.00 – 11.00
9:00 am Expanded Access 101: Understanding the Basics to Plan for & Manage a First Rate Expanded Access Program
Synopsis
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
11:00 am Morning Break & Networking
WORKSHOP B | 11.30 – 1.30
11:30 am Navigating Expanded Access for Early-Stage Companies: Balancing Patient Needs, Regulatory Hurdles, lifecycle Strategic Growth
Synopsis
Session details to be revealed
1:30 pm Afternoon Break & Networking
WORKSHOP C | 2.00 – 4.00
2:00 pm Overcoming Regulatory & Operational Challenges within APAC to Geographically Extend Patient Reach
Synopsis
Biopharma companies often hope to offer pre-approval access to patients outside of the US, but certain regions, particularly Asia-Pacific (APAC), present complex regulatory and operational challenges that can hinder this effort. This workshop will highlight these challenges and address what solutions may exist to help demystify pre-approval access in these markets to help in ethically expanding the global footprint of preapproval access.
Key Takeaways:
- Gain insights into the nuances in regulatory pathways and import regulations, as well as program design and opportunities in countries such as Japan, China and South Korea
- Understand the need for distributors and vendors in these programs, to ensure compliant operation and accelerated drug delivery to patients
- Lessons learned from recent examples of expanded access implementation in the APAC region