Achieving Orphan Designation (ODD) - Meeting the unmet need
Achieving Orphan Drug Designation is a significant step enabling your product to be licensed faster, in a cost-efficient manner, and achieve market exclusivity for 10 years.
Join this 1-hour webinar where you will gain a practical overview of the steps to achieve orphan status including:
- Review of the Orphan Drug Designation eligibility criteria, including a registered medicine with a new ‘orphan indication’
- An overview of Orphan Drug Designation incentives, such as tax, marketing approval and market exclusivity
- Practical application, process and insights
- EU & FDA requirements and assessing the differences