Recent US Regulatory Updates & Future Global Implications for EAPs

• Understanding how EAPs are shifting to integrated access and evidence models generating real-world data
• Accounting for how regulators are formalizing expectations on justification, risk– benefit, and alignment with development strategy
• Learning how external pressures shape expanded access, including MFN/pricing signals, FDA changes, and geopolitics

Speakers:

Emily Speas

Director, Regulatory & Pharmacovigilance

myTomorrows

Jill Beckley

Program Manager

myTomorrows