Case ReportCase Studies
A Case Study in Application of the Risk Knowledge Infinity Cycle
Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen and Kevin O’Donnell
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: https://doi.org/10.5731/pdajpst.2023.012931
Peer Schmidt
1AbbVie;
Martin J. Lipa
2TU Dublin & Pharmaceutical Regulatory Science Team (PRST); and
Jace Fogle
1AbbVie;
Owen Baker
1AbbVie;
Timothy Pawlak
1AbbVie;
Sean McEwen
1AbbVie;
Kevin O’Donnell
3Health Products Regulatory Authority (HPRA)

References
- 1.↵International Conference for Harmonisation. Quality Guideline Q10: Pharmaceutical Quality System Q10. ICH: Geneva, 2008. https://database.ich.org/sites/default/files/Q10Guideline.pdf
- 2.↵
- O’Donnell K.
- 3.↵International Conference for Harmonisation. Quality Guideline Q9: Pharmaceutical Quality System. ICH: Geneva, 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/%5CnGuidelines/Quality/Q9/Step4/Q9_Guideline.pdf
- 4.↵
- Calnan N.,
- Lipa M. J.,
- Kane P.,
- Menezes J. C.
- Calnan N.,
- Greene A.,
- Kane P. E.
- 5.↵
- Kane P. E.,
- Lipa M. J.,
- Greene A.,
- Calnan N. F.
- 6.↵ISPE. ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry; ISPE: Tampa, FL, 2021.
- 7.↵International Conference for Harmonisation. Final Concept Paper ICH Q9(R1): Quality Risk Management. ICH: Geneva, 2020.
- 8.↵International Conference for Harmonisation. Quality Guideline Q9(R1): Pharmaceutical Quality System. ICH: Geneva, 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2023_0126_0.pdf
- 9.↵
- Lipa M. J.,
- O’Donnell K.,
- Greene A.
- 10.↵
- Lipa M. J.,
- O’Donnell K.,
- Greene A
- 11.↵
- Lipa M. J.,
- O’Donnell K.,
- Greene A.
- 12.↵International Conference on Harmonisation. ICH Q9(R1) Training Materials; ICH: Geneva, 2023. https://database.ich.org/sites/default/files/ICH_Q9%28R1%29EWG_Training_Materials_2023_1005.zip
- 13.↵
- McEwen S.
- 14.↵
- Lipa M. J.,
- Mulholland V.
- 15.↵
- Lipa M. J.
- 16.↵
- Calnan N.,
- Lipa M. J.,
- Kane P.,
- Menezes J. C.
- Kane P. E.,
- Lipa M. J.
- 17.↵
- Beardsley S. C.,
- Johnson B. C.,
- Manyika J. M.
- 18.↵APQC. Introduction to Knowledge Management (KM). 2018. https://www.apqc.org/resource-library/resource-listing/introduction-knowledge-management-km-essentials-0.
- 19.↵
- Lipa M. J.,
- Mulholland V.,
- Greene A.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 3
May/June 2024
A Case Study in Application of the Risk Knowledge Infinity Cycle
Peer Schmidt, Martin J. Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O’Donnell
PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 367-383; DOI: 10.5731/pdajpst.2023.012931
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