Dr. Atalah Haun
Vice President, Global Medical Affairs WEP Clinical
Seminars
Wednesday 25th March 2026
The Hidden Cost of Poor EAP Operations: What Regulators Actually Notice
2:45 pm
- Expanded Access Programs may be non-pivotal but they are not non-consequential. Weak execution can blur the line between scientific uncertainty and operational failure, triggering regulatory friction, greater scrutiny, and more conservative decision-making
- Beyond endpoints, regulators assess governance of exposure, safety handling quality, traceability, eligibility discipline, product integrity, and consent rigor. Weak operational signals can erode confidence even before formal review discussions begin
- Well-executed EAPs preserve data interpretability, demonstrate organizational control, and build regulatory trust, preventing access programs from becoming liabilities and strengthening sponsor credibility during pivotal review and labelling discussions
