TY - JOUR T1 - Quality Risk Management - A Role-Based Competency Model JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2019.010496 SP - pdajpst.2019.010496 AU - Ghada Haddad AU - Anne Greene Y1 - 2019/01/01 UR - http://journal.pda.org/content/early/2019/09/13/pdajpst.2019.010496.abstract N2 - 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. ER -