Joint EFPIA/CHMP SWP workshop: the Emerging Use of Omic Technologies for Regulatory Non-Clinical Safety Testing.
A workshop was held on October 26-27, 2004, in Bonn, Germany, to discuss the potential use of omic technologies for regulatory non-clinical safety testing of pharmaceuticals. The meeting was hosted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The workshop was held in conjunction with the 6th European preclinical assessors meeting, which was organized in Bonn by the German Federal Institute for Drugs and Medical Devices (BfArM) and the Safety Working Party (SWP) of the Committee for Medicinal Products for Human Use (CHMP). Approximately 100 scientists, roughly half from the European pharmaceutical industry and half from European regulatory authorities, attended the workshop. The authors of this report constitute the organizing committee members.
Kasper
Peter
P
Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany. p.kasper@bfarm.de
Oliver
Gerry
G
Lima
Beatriz Silva
BS
Singer
Thomas
T
Tweats
David
D
D001709:Biotechnology / Q000379:methods / Q000592:standards; D004345:Drug Industry / Q000592:standards*; D005062:European Union; D023281:Genomics; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D040901:Proteomics; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*