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ATMP Trials Regulatory Manager to speak at Gene and Cell therapy course this week
23 January 2013
ATMP Trials Regulatory Manager Michelle Quaye will present on the topic of clinical trials regulations as part of a gene and cell therapy regulatory and translational module.
The Institute of Child Health is running this event as part of a Gene and Cell therapy MSC course, it is however also available as a standalone CPD training day.
The aim of this one day course is to introduce the regulatory requirements, procedures and practical aspects involved when designing and performing clinical trials for advanced therapy investigational medicinal products (ATIMPs), in particular cell and gene therapy.
Researchers and managers from academia and industry will be present to attain a better understanding of the regulatory aspects involved in running a clinical trial in the area of gene and cell therapy. Subjects covered include: regulatory requirements, The Human Tissue Act and examples of trials and translation from Industry.
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The JRO brings together expertise in research support, regulation, clinical trials, contracting, quality control and assurance, finance and study design and statistics.
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