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The QP assessment process

机译:QP评估流程

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摘要

Since the introduction of the EU clinical trials directive in UK law and the subsequent requirement for a Qualified Person to release pharmaceuticals for clinical trials, it has become apparent that there is a great shortage of QPs in the NHS who are able to perform this task for investigational medical products that are manufactured in hospitals. This is particularly true for radiopharmaceuticals, which, owing to their short shelf-life, nearly always need to be prepared on site and released immediately after manufacture.
机译:自从英国法律引入欧盟临床试验指令并随后要求合格人员发布用于临床试验的药品后,很明显,NHS中能够执行此任务的QP严重短缺。在医院生产的研究医疗产品。对于放射性药物而言尤其如此,由于它们的保存期限短,几乎总是需要现场准备并在制造后立即释放。

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