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Updated: Dec 29, 2025

An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
Quality Risk Management-A Role-Based Competency Model
Ghada Haddad1,2, Anne Greene2
1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and ghada.haddad@merck.com.
Abstract:
In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing quality risk management (QRM) role-based competencies as fundamental elements to realizing QRM's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in the paper titled "Quality Risk Management Competency Model-Case for the need for QRM Competencies." This paper presents the second part of the Delphi research methodology, focusing on the results of a detailed technical and behavioral competencies questionnaire and a proposed QRM role-based competency model.
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