Orphan Medicinal Product Designation in the EU 2015 is a webinar that covers topics such as:
- Legal background
- Introduction to Orphan Medicinal Product Designation in the EU
- Criteria for designation
- The COMP
- How to deal with subsets
- How to describe the medical condition
- Timing of designation
- Significant benefit
- Guidelines for Marketing Authorization procedures
- Procedure for obtaining designation
- Determinants for successful Marketing Authorizations
Orphan Medicinal Product Designation in the EU 2015 is intended for:
- CRAs
- Regulatory Affairs personnel
- Clinical Operations personnel
