Module 9 2024

03/09/2024

Can We Be Proactive About Change?

➢ Impact assessment, clearly defined TPP

➢ Post Approval Change Management Protocols (PACMP)

Comparability Protocols

➢ ICH Q12 / Q13

Established Conditions and CPV

➢ Lifecycle Management Protocols

The Organisation for Professionals in Regulatory Affairs

33

Common CMC Scenarios

The Organisation for Professionals in Regulatory Affairs

34

17