Market Access of Orphan Drugs

Aims and objectives:

The orphan drug sector is about to change. EU orphan drug and paediatric legislation is under review and the EU HTA is fast approaching - it is time for a thorough update on regulatory and HTA issues.

This course provides the latest on marketing authorisation and market access, as well as practical tips for evidence generation and value creation.

Topics:

- Evidence generation with small patient groups
- Evaluation of the orphan and paediatric legislation
- Orphan drugs in the German AMNOG procedure
- Value proposition from a health insurance perspective
- Value creation process for a launch in the EU4 and the UK

Who should attend?

This course addresses the needs of all who are involved in regulatory affairs or market access with small patient groups or orphan drug status. It is also recommended for those who address medical affairs and clinical issues related to orphan drugs.