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Scheduled Events CMC Simulation: A Hands-on Approach to Global Marketing Applications
Interactive Workshop on the Quality Section of Regulatory Submissions
Course Topics Include:
-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
To be presented at:
Parc Cientific de Barcelona
Baldiri Reixac 10
08028 Barcelona, Spain
For complete information see course brochure or
Call +34 934487156
or e-mail: info@sitec-pharmabio.com
