Currently the global market for biologics presents more than $ 130 billion. By 2016, the eight out of the ten blockbuster drugs will go off patent opening up the doors for generics and biosimilars. Becoming a steadily growing new field of biopharmaceutical development and bringing along safety and efficiency challenges, Fleming Europe has organized the CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters.WHO WILL ATTENDVice Presidents, Directors, Heads, Managers and Scientists involved in:Biologics, Biosimilars, Biobetters, Copy Biologics, Biopharmaceuticals, Biotechnology, Biotherapeutics, Analytical Science, Process Science, Research & DevelopmenThe 2-day MasterClass will    Highlights the regulatory, scientific and technical challenges and opportunities involved    Provides an opportunity to learn the dos and the don’ts from the experts in this field    Represents a platform to discuss development challenges, technical hurdles, and regulatory expectations associated with Quality by Design and CMC characterization / comparability studies    Introduces state-of-the art analytical methods and concepts (analytical characterization of biosimilars and reference product, quality target product profile, aceptable range of variability, justification of differences)    Presents case studies of originator biologics and biosimilar products including examples addressing the development of biosimilar monoclonal antibody products    Provides insight into the latest regulatory requirements and technical aspects for successful development a nd analytical comparability/similarity studies