1st Workshop, Barcelona: “Compassionate Access Programmes for Orphan Drugs in Europe: from Heterogeneity to Harmonised Practices?”
1st Workshop of the Eurordis Round Table of Companies:
“Compassionate Access Programmes for Orphan Drugs in Europe: from Heterogeneity to Harmonised Practices?”
December 17th, 2004
With the aim to address the implementation of EMEA’s new responsibilities as regards compassionate access programmes, as provided for in EC/EP Regulation 726/2004, recital 331 and article 83, this first meeting focussed on patients’ expectations, and identified obstacles, advantages, and good practices both from competent authorities and industry perspectives.
Key feature: launch of the ERTC workshops
1 REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products, for human and veterinary use and establishing a European Medicines Agency