CMC Simulation: A Hands-on Approach to Global Marketing Applications

30/06/2016 - 01/07/2016

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