Post-Trial Access in Practice: Navigating Unlicensed Pathways
- Why Post-Trial Access programs are rapidly increasing and what’s driving this global shift
- Common regulatory pathways and country-specific constraints sponsors often underestimate
- Complexities with a locally licensed drug for non-approved indications
- Managing timelines, cost drivers, and patient attrition expectations in PTA programs
- Scoping information required for accurate planning and quotations