Alastair Coupe
Articles
A guide to EFPIA's Mock P.2 document
Gerd Fischer;Alastair Coupe;Alistar Swanson;Stephan Roenninger;Fritz Erni;Gordon Muirhead;Chris Potter;Rafæl Beerbohm;Staffan Folestad
December 1st 2006EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
Latest Updated Articles
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: February 23rd 2024 | Updated: December 21st 2024
Europa Perspectives: Helping to Navigate the Regulatory System
Published: December 13th 2024 | Updated: December 21st 2024
FDA Creates CDER Center for Real-World Evidence Innovation
Published: December 5th 2024 | Updated: December 21st 2024
Leveraging Advancements in Bioanalytical Testing
Published: December 7th 2024 | Updated: December 21st 2024
Exploring Opportunities for LNP Delivery in mRNA
