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
