Implementing ATMPs can be disruptive to the “business as usual” aspects of running an NHS healthcare organisation. This presentation will focus on the “last 100m”, when the medicine has its marketing approval and commissioned sites have been identified but patients have not yet been treated. It will aim to provide an overview of governance, operational and clinical challenges which need to be overcome in order to implement these novel medicines which are offering real change for patients.
Regional Quality Assurance (QA) Specialist Pharmacist for the North East & North Cumbria
Newcastle upon Tyne Hospitals NHS Foundation Trust
Anne Black is Regional Quality Assurance (QA) Specialist Pharmacist for the North East & North Cumbria. She is based at Newcastle upon Tyne Hospitals NHS Foundation Trust and plays an active role in the Northern Alliance Advanced Therapy Treatment Centre (NA-ATTC).
After qualifying as a pharmacist in 1991, Anne began her career at The Ipswich Hospital NHS Trust as a Basic Grade Pharmacist and subsequently became the QA Pharmacist. She was one of the first cohort of students to study for and attain the Postgraduate Diploma in Pharmaceutical Technology and Quality Assurance from the University of Leeds. She later returned to the North East, spending three years as Technical Services Manager for a commercial Specials Manufacturer before returning to the NHS in a QA role. Anne took up her current post in July 2017.
Anne is a Qualified Person for Investigational Medicinal Products and has developed a particular interest in advanced therapy medicinal products (ATMPs) since becoming involved with quality management of the Newcastle Cellular Therapies facility. She advocates and champions pharmacy governance for ATMPs and is Chair of the UK Pharmacy Working Group for ATMPs.