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Preview Past FDA Speaker Presentations
Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry
Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies
November 09-10, 2015 · Hyatt Regency Reston · Reston, VA
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Alexion Pharmaceuticals · Allergan · Amgen Inc. · Astellas Pharma · Baxter · Bayer Healthcare · Biogen Idec · Boehringer Ingelheim · Bristol Myers & Squibb · Cephalon · Crucell · CSL · Daiichi Sankyo · Dr. Reddy's Laboratories · Eli Lilly & Co. · Emergent Biosolutions · Endo Pharmaceuticals · Forte Bio · Genentech Inc. · GlaxoSmithKline · Grifols · Hoffman La Roche · Hospira · Janssen · Johnson & Johnson · Kyowa Hakko · Merck & Co. · Millennium Pharmaceuticals · Novartis · Novo Nordisk · Pfizer · Sanofi Pasteur · Shire · Takeda Pharamceutical Co. · Teva Pharmaceuticals