DDA31 Orphan Medicinal Drug Products

To provide participants with an understanding of how to prepare the scientific part of an orphan designation application and to recognise strategies used in clinical development of an orphan medicinal product.

Participant profile: This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.