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

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.