4th Workshop, Barcelona: “Common Drugs for Common Needs:the US vs EU Approach to OMP Development”

4th Workshop of the Eurordis Round Table of Companies:

“Common Drugs for Common Needs:the US vs EU Approach to OMP Development”


June 30th, 2006

Barcelona, Spain

panel of speakersThis workshop marked an unprecedented partnership between FDA, EMEA and EURORDIS and a concensus was gained on the possibility of a fruitful coordination between the two systems, which appeared to have many similarities. This would translate into faster development and fewer failures, resulting in easier access to Orphan Medicinal Product for patients.

Participants: 41

Key feature: successful outcome with the general agreement on a joint FDA-EMEA application form for Orphan Medicinal Product designation


Concept Paper


For ERTC Members only, this document is password protected. If you want to become a member, find out more here or contact Anne-Mary Bodin, Operations Assistant.


The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseasesRare Disease International Bringing together patients, families and experts to share experiences in a moderated multi-language forum. RareConnect The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases