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 will be published summer 2024 which will feature the conference proceedings of the innovative Quality Business Leadership Summit, which will be held on 01-May-2024 at TU Dublin. Click here for a preview of the programme.
Current Issue: Volume 1, Issue 1 (2024) Industry One-Voice-of-Quality (1VQ) for Post-Approval Changes (PAC) + FoReSight
Table of Contents
Table of Contents
Anne Greene (editor), Martin J. Lipa (editor), and Kevin O'Donnell (editor)
Preface
The Birth of a Journal
Anne Greene, Kevin O'Donnell, and Nuala Calnan
Articles
The Ongoing Journey of the One Voice of Quality for Post-Approval Changes (1VQ for PAC) Initiative
Anders Vinther and Emma Ramnarine
One-Voice-of-Quality (1VQ) Industry Position Paper: Shelf-Life Extensions for Pharmaceutical Products
Nasir Egal and Kevin Lombardi
One-Voice-of-Quality (1VQ) Industry Position Paper: Changes to Analytical Equipment/Instrumentation that are Deemed Equivalent
Richard Rolke and Emma Ramnarine
Lessons Learned from COVID-19 is an Opportunity to Reduce Drug Shortages - Vision and Practical Solutions
Anders Vinther
Applying Systems Thinking to Navigate the Global Regulatory Complexity Problem for Post-Approval Changes
Emma Ramnarine and Anders Vinther
FoReSight: Trusting and Using the Information from Data Analytics to Support Decision-Making in Pharmaceutical Manufacturing
Marcus O’Mahony, Paul Bassett, Alan Kavanagh, Anthony Maguire, Aoife Corrigan, Barry Malone, Michael Walshe, Siobhán Griffin, Thomas Coleman, Margot Holland, Kate Courtney, Carl Rafferty, Anne Greene, and Damon Warnock
