From 30 June 2016 to 1 July 2016
Interactive Workshop on the Quality Section of Regulatory Submissions.
Real hands-on, practical case studies, for small and large biological molecules in a simulation format.
Strategic writing for the CMC section of global marketing application(s).
Traditional and enhanced (Quality by design) approaches.
Agency reviewer assessment-key technical/regulatory issues.
Special considerations and best practices for ICH (US, EU and Japan) and major ex-ICH countries.