Virus safety evaluation of biotechnological investigational medicinal products - Scientific guideline
Table of contents
This document provides scientific guidance on the viral safety of biotechnological medicinal products used in clinical trials.
Keywords: Virus safety, clinical trial, investigational medicinal products (IMPs)
-
List item
Overview of comments received on draft guideline on virus safety evaluation of biotechnological investigational medicinal products (PDF/320.89 KB)
First published: 17/09/2008
Last updated: 17/09/2008
EMEA/CHMP/BWP/67410/2007 -
List item
Draft guideline on virus safety evaluation of biotechnological investigational medicinal products (PDF/101.45 KB)
Draft: consultation closed
First published: 28/06/2006
Last updated: 28/06/2006
EMEA/CHMP/BWP/398498/2005-corr -
List item
Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials (PDF/144.59 KB)
First published: 15/12/2004
Last updated: 15/12/2004
EMEA/CHMP/BWP/124447/2004