9th Annual Biomarkers Congress

Biotechnology: Food and Drug Administration

Total Score People Score Events Score
10 10 7
Date Event Presentation Speakers
April 6, 2013 AACR Annual Meetings Personalized Medicine in Clinical Trials: What You Need to Know Now Elizabeth Mansfield, U.S. Food and Drug Administration, Rockville, MD Elizabeth Mansfield
February 20, 2012 International Conference and Exhibition on Metabolomics & Systems Biology Track 1-5: Metabolomics and Toxicology Laura K. Schnackenberg
February 6, 2011 5th Drug Discovery for Neurodegeneration: An Intensive Course for Translating Research into Drugs Regulatory Requirements in Preparing for Clinical Trials Eric Bastings
August 17, 2010 Production & Manufacturing of Vaccines Opening Keynote Presentation | Regulatory Authority Perspective on Handling Vaccine Production, Manufacturing and Process Change Norman Baylor
March 17, 2009 Bio Medical Asia 2009 A regulatory approach to Quality-by-Design for biotechnology products Steve Kozlowski
November 12, 2007 Well Characterized Biologicals - Continuous Evolution of Chemo- and Bioanalytical Approaches Nov(12 - 14) Regulatory Perspectives (13:25-17:00) Emily Shacter, Malcolm Moos, Kathleen A. Clouse
Regulatory Perspectives: Assessing Impurities in Biotherapeutics (16:00-16:30) Kathleen A. Clouse
Regulatory Perspectives: Potency Issues - Cell-Based Functional Assays vs. Binding Assays (14:30-15:00) Emily Shacter
Regulatory Perspectives: Problems and Limitations with Analytical Methods - A Regulator's Perspective (15:30-16:00) Malcolm Moos
Impact of Extractables and Leachables on Well Characterized Protein Products (10:45-13:25) Ingrid Markovic
Impact of Extractables and Leachables on Well Characterized Protein Products: Regulatory Considerations for Evaluating the Impact of Extractables and Leachables - A Risk-Based Approach (10:45-11:15) Ingrid Markovic
September 30, 2007 BioProcess International Conference & Exhibition Plenary Session : Keynote Presentations and Featured Discussion (14:00 - 18:00) Helen N. Winkle
Plenary Session ; Keynote Presentations and Featured Discussion : Regulatory Modernization Helen N. Winkle
4th Annual Pharma R&D Asia Congress
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