| Affiliation: | 1.Technical Regulatory Policy,Genentech, a Member of the Roche Group,Washington, DC,USA;2.Regulatory-CMC,Bristol-Myers Squibb Company,New York,USA;3.Biologics Process Development & Commercialization,Merck & Co., Inc.,Kenilworth,USA;4.Biologics CMC Regulatory Affairs,Merck & Co., Inc.,Kenilworth,USA;5.Technical Research and Development,Novartis Pharmaceuticals Corporation,Hannover,USA;6.Regulatory Affairs, CMC,Pharmacyclics Inc.,Sunnyvale,USA;7.Quality and Technical Operations,Pharmacyclics Inc.,Sunnyvale,USA;8.Regulatory Affairs,Amgen,Thousand Oaks,USA;9.Global Chemistry Manufacturing & Controls,Pfizer Inc.,New York,USA;10.Biosimilars and Biologics Policy, Office of Biotechnology Products,CDER, U.S. FDA,Silver Spring,USA;11.Office of Pharmaceutical Quality,CDER, U.S. FDA,Silver Spring,USA;12.CDER, U.S. FDA,Silver Spring,USA |
