Annmarie Galli
Head, Global Medical Affairs Research & Compassionate Use/ Managed Access Programs GlaxoSmithKline
Seminars
Wednesday 25th March 2026
Panel Discussion: Driving Smarter Decisions by Clarifying the Role of RWD in EAPs
12:00 pm
- Comparing how FDA, EMA, and national health authorities interpret the use of RWD in expanded and post-trial access programs
- Examining differing company approaches, from limiting programs to treatment-only access to actively incorporating structured evidence generation
- Exploring real-world examples of where regulators accepted or rejected RWD submissions in filings and approvals
- Defining the boundaries of ethical and compliant RWD collection when patient care is the primary purpose
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
