CMC Strategy Forum Europe 2013
06 May 2013 - 08 May 2013 - Prague, Czech Republic
The seventh annual CMC Strategy Forum Europe, organized by CASSS - An International Separation Science Society, will explore a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. A series of plenary sessions and workshops led by experts from global regulatory agencies, academia and industry seek to explore emerging aspects of CMC technology and regulation in areas where existing modalities and systems are undergoing change. Plenary topics will include process validation, regulatory perspectives on the modernization of the industry and change management protocols. Workshops will provide the opportunity for in-depth discussions on control strategy and its lifecycle management beyond specifications, scope and limitations of bioassays, the QbD implementation phase and related issues for devices and combination products.