Leigh-Ann Durant
Head of North America Medical Governance, Chief Medical Officer Governance & Operations, Strategy, Portfolio, & Hubs EMD Serono
Seminars
Monday 23rd March 2026
Workshop C: Managing EAPs End-to-End: Practical Tools to Deliver Timely & Compliant Access
2:45 pm
- Mastering operational steps from program initiation through supply planning, labelling, and logistics
- Learning tactics for improving physician and site engagement to accelerating patient treatment
- Understanding how to anticipate and mitigating common operational and regulatory challenges
- Exploring strategies for program closure or transition to ensuring seamless patient access
Wednesday 25th March 2026
Navigating Global Differences & Business Decisions in Expanded Access Programs
11:30 am
- Compare regulatory frameworks and access pathways across the US (FDA), Europe (EMA), and other national systems such as France’s ATU
- Explore how approaches to expanded access differ between large pharma and smaller biotech organizations.
- Examine how companies assess the business case and operational feasibility of launching programs in emerging regions, including the Middle East and Latin America
