Annmarie Galli
Global Head of Medical Affairs Research & Compassionate Use & Managed Access Programs GlaxoSmithKline
Seminars
Thursday 26th March 2026
Operating EAPs In-House, Hybrid, or Fully Outsourced: Finding the Right Model
12:15 pm
- Comparing the pros and cons of fully in-house, fully outsourced, and hybrid approaches to program management
- Leveraging vendor expertise for complex countries or niche therapies while maintaining control over core markets
- Learning from real-world case studies on outsourcing, internalizing, and transitioning programs smoothly
Wednesday 25th March 2026
Expanded Access in 2026: New Guidance, Evolving Expectations, and What People Need to Know
8:30 am
- What has changed with the latest FDA Expanded Access guidance and what this means for sponsor decision‑making and risk‑benefit considerations?
- How evolving expectations around post‑trial access, use of real‑world data, and charging may reshape Expanded Access strategies
- Opportunities for sponsors, with key practical suggestions for program design, governance, and stakeholder engagement
