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 QRM role-based competencies, as fundamental elements to realizing Quality Risk Management 's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in 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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