The five process groups of a process-based approach to project management are: Initiate, Plan, Execute, Monitor and Control, and Close, according to the Project Management Body of Knowledge Guide (PMBOK). This article presents opportunities for using a project management framework when strategising for CMC regulatory submission projects. The authors discuss PMBOK nomenclature, project performance domains, project constraints, process groups, examples of scenarios that may be encountered during a submission project, and templates that can be used to support the project framework.
Rapp EA, Imperial R. Application of project management strategy to postapproval CMC submissions.
RF Quarterly. 2022;2(3):42-51. Published online 30 September 2022.