Editors
| Editors: | Professor Anne Greene, TU Dublin & Pharmaceutical Regulatory Science Team |
|---|---|
| Professor Kevin O’Donnell, TU Dublin & Pharmaceutical Regulatory Science Team | |
| Dr Marty Lipa, TU Dublin & Pharmaceutical Regulatory Science Team |
The Journal of Applied Pharmaceutical Regulatory Science (JAPRS), an occasional on-line journal, was founded by the editors in 2024. The intent of the journal is to provide a means of capturing, aggregating and disseminating regulatory science research, initiatives and approaches which advance activities in the commercial phase of a pharmaceutical product lifecycle that lead to enhanced quality and availability of medicines to a global patient population.
The inaugural issue of the Journal of Applied Pharmaceutical Regulatory Science (Volume 1 Issue 1) was published in April 2024 and features open-access articles from the One Voice of Quality for Post-Approval Changes Initiative (1VQ for PAC).
Volume 1 Issue 2 was published in October 2024 and features the conference proceedings of the Quality Business Leadership Summit, held on 01-May-2024 at TU Dublin.
Current Issue: Volume 1, Issue 2 (2024) Taking a Stand for Quality by Advancing Pharmaceutical Quality Leadership, Quality Risk Management & Knowledge Management
Table of Contents
Preface
From Quality Management to Quality Business Leadership: The critical role of leadership, employee engagement and trust for innovation and continuous improvement
ASHLEY O'DONOGHUE, Colin Hughes, and Anne Greene (editor)
Articles
Working Towards a Global Quality Dossier – Quality Leaders Turning Concept into Possibility
Lorraine Nolan
Taking a Stand for Pharmaceutical Quality
Janet Woodcock
ICH Q9(R1): The Quality Leader’s Opportunity for Effective, Patient-centric Decision-making
Kevin O'Donnell
Quality Business Leadership Summit: Panel Discussion with Keynote & Morning Session Speakers
Anders Vinther, Janet Woodcock, Kevin O'Donnell, Holger Rathgeber, and Lorraine Nolan
Quality’s Role in Partnering with Operations
Paul O'Neill
The Quality Professional as The Business Leader
Pat O'Mahony
Quality Business Leadership Summit: Panel Discussion with Afternoon Session Speakers
Janet Woodcock, Jane Wyatt, Anders Vinther, Maureen Larkin, Cathal Elliott, and Pat O'Mahony
Taking a Stand for Quality Demonstrating PQS Effectiveness by Operationalising QRM and KM
Kevin O'Donnell, Martin J. Lipa, and Anne Greene (editor)
