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

doi:10.5731/pdajpst.2023.012931

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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;

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Martin J. Lipa

2TU Dublin & Pharmaceutical Regulatory Science Team (PRST); and

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For correspondence: martin.lipa@prst.ie

Jace Fogle

1AbbVie;

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Owen Baker

1AbbVie;

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Timothy Pawlak

1AbbVie;

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Sean McEwen

1AbbVie;

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Kevin O’Donnell

3Health Products Regulatory Authority (HPRA)

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vol. 78 no. 3 367-383

DOI

https://doi.org/10.5731/pdajpst.2023.012931

PubMed

38942476

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 28, 2024.

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previous version (April 25, 2024 - 12:21).
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Author Information

Peer Schmidt¹,
Martin J. Lipa^2,*,
Jace Fogle¹,
Owen Baker¹,
Timothy Pawlak¹,
Sean McEwen¹ and
Kevin O’Donnell³

¹AbbVie;
²TU Dublin & Pharmaceutical Regulatory Science Team (PRST); and
³Health Products Regulatory Authority (HPRA)

↵* Corresponding Author: Doylestown, PA 18902; E-mail: martin.lipa{at}prst.ie

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PDA Journal of Pharmaceutical Science and Technology

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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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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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Keywords

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

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