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Out of specification ATMPs – webinar
14 September 2021 • 4:00 pm - 5:00 pm
Due to the unique nature of cell or tissue-based ATMPs, there may be occasions when the manufactured medicine is not in full compliance with the release specification, yet it may be in the patient’s best interest to allow administration of the out-of-specification (OOS) medicine. Administration of OOS ATMPs is exceptionally permissible from a regulatory perspective. It, however, poses challenges to the NHS. The aim of the webinar is to showcase the Pan UK Pharmacy Working Group for ATMP’s pragmatic advice which clarifies the regulatory perspective regarding OOS ATMPs, and provides guidance to NHS organisations which are provider sites for ATMPs, about governance in the event of an OOS ATMP being supplied for one of their patients.