PT  - JOURNAL ARTICLE
AU  - Haddad, Ghada
AU  - Greene, Anne
TI  - Quality Risk Management Competency Model- Case for the need for QRM Competencies
AID  - 10.5731/pdajpst.2019.009944
DP  - 2019 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.009944
4099  - http://journal.pda.org/content/early/2019/05/15/pdajpst.2019.009944.short
4100  - http://journal.pda.org/content/early/2019/05/15/pdajpst.2019.009944.full
AB  - Abstract The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, recently conducted a Quality Risk Management (QRM) survey and a face-to-face focus group workshop to assess the level of formality of QRM roles in the biopharmaceutical sector. This was carried out as part of a research study, which identified the need for the development of QRM role-based competencies, as fundamental to realizing QRM’s benefits. The research study followed a hybrid Delphi research methodology comprised of: • Survey 1 • Focus Group Workshop • Survey 2 • Competency Model Development This paper presents the results of survey 1 and the Focus Group Workshop. Survey 1 explored the need for QRM role-based competencies and the subsequent face-to-face Focus Group Workshop built on this to propose initial standard QRM roles, with a view to confirming these, with the purpose of developing associated competencies. This paper presents the finding from Survey 1 and the Focus Group Workshop The results of the follow-on research activities will be presented in a subsequent paper entitled: Quality Risk Management Competency Model -Developing Competencies and Presenting the Model