Articles
Mapping KM Methods and Tools across the Pharmaceutical Product Lifecycle
Martin Lipa and Paige Kane
PART 1: Research articles from PhD research candidates, PRST, TU Dublin
Managing Knowledge and Risk:a Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers
Marty Lipa, Kevin O'Donnell, and Anne Greene
Knowledge as the Currency of Managing Risk: a Novel Framework to Unite Quality Risk Management and Knowledge Management
Martin J. Lipa, Kevin O'Donnell, and Anne Greene
The Regulatory Landscape for ATMPs in the EU and US: a Comparison
Shada Warreth and Elaine Harris
Regulatory Readiness Level: a Tool to Enhance Early Regulatory Adoption in Academic Discovery
Eamonn McGowran and Elaine Harris
Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making
Valerie Mulholland and Anne Greene
QRM: a Case for Convergence: a Reminder that Quality Risk Management Must Work With Other Risk Management Systems
Valerie Mulholland
PART 2: Research articles from MSc cohorts on the Pharmaceutical Validation Technology (PVT) and Pharmaceutical Quality Assurance (PQA)programmes, PRST, TU Dublin
From Idea to Therapeutic: Is There a Role for Developing a Regulatory Pathway Tool for Early Stage Research?
Elaine Harris and Eimear O'Reilly
Exploring the Advantages of Implementing ICH Q12
Susan McDonagh
Development of the Self Inspection Programme to Assist Demonstrating PQS Effecetiveness
Helena Scully and Fiona O'Sullivan
Introducing SI-PEA: a Risk-based Tool to Measure the Effectiveness of Your Self-inspection Programme
Maria Makarevich and Valerie Mulholland
Assessing If Patients Would Benefit From Electronic Patient Information Leaflets (ePils)
Maria Gormley
PART 3: Research articles from collaborative work with global colleagues and stakeholders
Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS):Through Enhanced Science and Risk-Based Approaches Changes to Analytical Equipment/Instrumentation that are Deemed Equivalent
Emma Ramnarine, Richard Rolke, and Kevin O'Donnell
Covid -19 and the Need for Robust Risk Control Strategies: Can ICH-Q9 Help?
Umit Kartoglu, Kevin O'Donnell, and James Vesper
Understanding the Concept of Formality in Quality Risk Management
Kevin O'Donnell, Deirdre Tobin, Stephanie Butler, Ghada Haddad, and Donal Kelleher
Simple Practices to Facilitate the Flow of Valuable Tacit Knowledge During Biopharmaceutical Technology Transfer: a Case Study
Martin Lipa, Paige Kane, and Anne Greene