CMC Strategy Forum Europe 2014
05 May 2014 - 07 May 2014 - Sorrento, Italy
The eighth annual CMC Strategy Forum Europe organized by CASSS will be held 5-7 May 2014 at the Hilton Sorrento Palace Hotel in Sorrento, Italy. The CMC Strategy Forum includes case study presentations followed by a panel discussion to engage all the participants who have experience and expertise to share. A series of plenary sessions and workshops led by experts from global regulatory agencies, academia and industry provide an open forum for dialogue and exchange of scientific and technical advances that are the basis for evolution of regulatory practices. The following topics will focus on improving the quality in development and manufacturing of biopharmaceutical products: comparability and similarity; lifecycle approach to process validation; quality assurance and how to ensure successful QbD submissions; multi-site supply chains and initiatives to accelerate product development and regulatory implications. It should be important for you to attend this event as we come together to discuss important issues on how to ensure product safety and efficacy for the patients we serve.