Richard Klein
Director - Expanded Access Programs & Policy GE2P2 Global Foundation
Seminars
Wednesday 25th March 2026
Setting the Stage – Expanded Access in 2026: From Ethical Imperative to Strategic Necessity
8:30 am
-  Discussing how EAPs have evolved since their inception, from ad hoc programs to strategic global tools
- Highlighting the key forces shaping the landscape today: regulatory variability operational challenges, supply pressures, and the not-so-subtle shift toward data collection for regulatory purposes
- How EAPs are redefining their role and impact as vehicles for generating Real World Data/Evidence in clinical development and commercialization
Wednesday 25th March 2026
Fireside 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
