Current Global GMP Status and Trends With Focus on EU & PIC/S JPMA Annual Meeting, Tokyo & Osaka, September 2012 Dr.-Ing. Stephan Rönninger Pharma Medicines Technical Operations Global Quality & Compliance , …
english only final expert committee on biological standardization geneva, 19 to 23 october 2009 guidelines on evaluation of similar biotherapeutic products (sbps)
1 2 WHO/BS/2016.2290 3 ENGLISH ONLY 4 5 Guidelines on evaluation of monoclonal antibodies as 6 similar biotherapeutic products (SBPs) 7 8 NOTE: 9 This document has been prepared for the purpose of inviting comments and suggestions on the 10 proposals contained therein, which will then be considered by the Expert Committee on 11 Biological Standardization (ECBS).