Module 9 2021

19/03/2021

Can We Be Proactive About Change?

 Impact assessment, clearly defined TPP

 Post Approval Change Management Protocols (PACMP) Comparability Protocols

 ICH Q12

Established Conditions

 Lifecycle Management Protocols

The Organisation for Professionals in Regulatory Affairs

31

Established Conditions

The Organisation for Professionals in Regulatory Affairs

32

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