BioInsights - Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

Evolving ATMP regulations in the EU & UK, & the role of the Qualified Person

Cell & Gene Therapy Insights 2022; 8(6), 697–705

DOI: 10.18609/cgti.2022.106

Published: 9 July 2022
David Caulfield

David Caulfield is currently Assistant Director of Pharmacy – Quality Assurance at Newcastle upon Tyne Hospitals NHS Trust, he has spent his career working in the NHS, briefly in clinical pharmacy roles and latterly in production and quality assurance roles. David is passionate about delivering high quality care and with a love for science and innovation he was drawn to the field of advanced therapies. David passed his Qualified Person VIVA in 2016 and has been an operational Qualified Person across numerous dosage forms since then. He is now a Qualified Person Assessor on behalf of the Royal Pharmaceutical Society, and is passionate in supporting candidates within the NHS and industry in their own QP journeys, including lecturing at The University of Manchester where he did his original undergraduate degree. He has a unique perspective of the disruption that can face the NHS in adopting these exciting therapies, but also an understanding of the extremely complicated and highly regulated area of manufacture, David now assists industry in the shaping the design of the next generation of ATMPs to optimise adoption, maximising the incredible promise many of these therapies offer.