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Pharmacy Administration, Policy and Regulation Commons™
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- Knowledge management (3)
- Quality risk management (2)
- (KM) (1)
- COVID-19 (1)
- Community pharmacy (1)
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- Data (1)
- FDA (1)
- Interpretative Phenomenological Analysis (IPA) (1)
- Knowledge management (1)
- Pharmaceutical quality system (1)
- Pharmaceutical industry (1)
- Pharmaceutical knowledge product life cycle (1)
- Pharmaceutical quality system. (1)
- Pharmaceutical sector (1)
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- Quality risk management (QRM) (1)
- Quality control (1)
- Regulation (1)
- Risk assessment (1)
- Risk knowledge infinity cycle (1)
- Risk management in healthcare; recoding quality risk management; patient welfare; pharmaceutical industry; biopharmaceutical industry. (1)
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Articles 1 - 7 of 7
Full-Text Articles in Pharmacy Administration, Policy and Regulation
At War With A Silent Killer: An Ipa Study Of The Lived Experiences Of Community Pharmacists In Ireland During Covid-19, Regina Brady, Niamh Imbusch
At War With A Silent Killer: An Ipa Study Of The Lived Experiences Of Community Pharmacists In Ireland During Covid-19, Regina Brady, Niamh Imbusch
Articles
Objectives: The purpose of this research was to give voice to the unique lived experiences of community pharmacists who continued to work in patient-facing roles throughout the COVID-19 pandemic. Research objectives sought to understand how they felt about working during this time including any risks felt, why they choose to continue working, and what the post-COVID future might hold for them and their profession. Method: The study was guided by the principles of traditional interpretative phenomenological analysis (IPA). Primary research was collated using semi-structured interviews of a small, purposively selected homogenous group of pharmacists. The research context was a …
“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)
“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)
Level 3
Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.
Unlocking Knowledge To Benefit The Patient : How Connecting Km And Qrm Can Strengthen Science And Risk-Based Decision Making, Martin J. Lipa
Unlocking Knowledge To Benefit The Patient : How Connecting Km And Qrm Can Strengthen Science And Risk-Based Decision Making, Martin J. Lipa
Doctoral
This thesis explored knowledge management effectiveness in the pharmaceutical sector and included an examination of the critical relationship between knowledge management (KM) and quality risk management (QRM) as the dual enablers of an effective pharmaceutical quality system. The primary research objectives were to improve understanding and effectiveness of the interdependency between KM and QRM and to improve knowledge management across the pharmaceutical product lifecycle, starting with a focus on knowledge transfer during technology transfer. The thesis explored how improved KM across the product lifecycle coupled with thoughtful and intentional connectivity between KM and QRM as defined by this study could …
A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene
A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene
Level 3
As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …
Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane
Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane
Level 3
Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.
Introducing A Model And A Framework To Unify The Pharmaceutical Quality System Enablers Quality Risk Management & Knowledge Management, Martin J. Lipa, Kevin O'Donnell, Anne Greene
Introducing A Model And A Framework To Unify The Pharmaceutical Quality System Enablers Quality Risk Management & Knowledge Management, Martin J. Lipa, Kevin O'Donnell, Anne Greene
Articles
An organization that effectively manages knowledge should be able to recognize and proactively apply new learnings to better anticipate risks. This is particularly important in the manufacture of medicinal products. Since the publication of ICH Q10 in 2010, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System. The authors of this paper present a Knowledge Management process model to foster greater practical understanding of the practice of knowledge management. This model when joined with the familiar ICH Q9 process model for QRM, should enable a company to better manage their knowledge …
Managing Risk To The Patient: Recoding Quality Risk Management For The Pharmaceutical And Biopharmaceutical Industries, Kelly Waldron
Managing Risk To The Patient: Recoding Quality Risk Management For The Pharmaceutical And Biopharmaceutical Industries, Kelly Waldron
Doctoral
This thesis explores the application of quality risk management (QRM) in pharmaceutical and biopharmaceutical companies and its effectiveness at managing risk to the patient. The objective of the research described in this thesis was to characterize a maturity state of QRM implementation in which the patient is adequately protected from the risks associated with medicinal products of inadequate quality. The research was conducted over three phases: first, to determine whether patients are better protected since the publication of ICH Q9, a commonly employed guidance on the application of QRM; second, to characterize the industry with regard to QRM maturity, including …