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