EMEA guideline on Cell Based Medicinal Products (CBMP)

BruCells has been actively involved in the discussion of the EMEA guideline on Cell Based Medicinal Products (CBMP). Catherine De Greef was present at the DC-THERA Cluster 4 Meeting in Bamberg (July 2007) where among other topics these guidelines were discussed and where the basis for a written statement has been worked out. During the finalisation of the statement, BruCells has mainly put forward the notion that the guidelines are not suitable to CBMP for the authorization of investigational trials, but are applicable in the procedure of obtaining market approval.

created over 16 years ago (2 March 2009)    last modified over 13 years ago (28 May 2012)   [ RDF ]   [ RelFinder ]