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Design as a driver of user-centred innovation

The Commission staff working document on Design as a driver of user-centred innovation provides an analysis of the rationale for making design an integral part of European innovation policy. The questions below are based on the document. Their aim is to find out whether more should be done at EU level in the area of design and if so, what.

 
Good clinical practice specific to advanced therapy medicinal products

Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance.

 
Data fields of the clinical trials database (EudraCT) and info on trial results for paediatric clinical trials

In Feb-Apr 2008, a public consultation was conducted on a draft Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with article 41 of Regulation No. (EC) 1901/2006. In this draft guidance, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results for paediatric clinical trials to be made publicly available. DG ENTR now launches a public consultation on this draft list.