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OtherCase Studies

Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) 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 April 2024, pdajpst.2023.012931; DOI: https://doi.org/10.5731/pdajpst.2023.012931
Peer Schmidt
1 AbbVie;
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  • For correspondence: peer.schmidt@abbvie.com
Martin J Lipa
2 Pharmaceutical Regulatory Science Team (PRST);
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Jace Fogle
1 AbbVie;
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Owen Baker
1 AbbVie;
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Timothy Pawlak
1 AbbVie;
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  • For correspondence: timothy.pawlak@abbvie.com
Sean McEwen
1 AbbVie;
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  • For correspondence: sean.mcewen@abbvie.com
Kevin O'Donnell
3 HPRA
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  • For correspondence: kevin.odonnell@hpra.ie
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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle
Peer Schmidt, Martin J Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology Apr 2024, pdajpst.2023.012931; DOI: 10.5731/pdajpst.2023.012931

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Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle
Peer Schmidt, Martin J Lipa, Jace Fogle, Owen Baker, Timothy Pawlak, Sean McEwen, Kevin O'Donnell
PDA Journal of Pharmaceutical Science and Technology Apr 2024, pdajpst.2023.012931; DOI: 10.5731/pdajpst.2023.012931
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Keywords

  • ICH Q9(R1)
  • RKI Cycle
  • Risk based decision making
  • knowledge management
  • pharmaceutical quality system
  • quality risk management

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