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药物非临床研究质量管理规范(GLP)实施中最主要、最关键的环节是人员。人员的GLP意识、专业技术能力的培养至关重要,因此GLP机构中人员的教育培训工作应贯穿于整个职业生涯。通过对当前GLP机构中人员培训存在的问题及培训的重要性进行总结,从培训分类、培训要求及国内外现状等方面进行比较与讨论,阐明唯有切实有效的培训方能为GLP机构培养有资质的合格人员,使人员具有正确的法规理念和GLP意识、扎实的专业知识、熟练的操作技能、优秀的团队意识,才能从根本上提高药物临床前安全性评价质量并促进GLP机构长足发展。
Nonclinical research The most important and crucial aspect of the GLP implementation is personnel. Personnel GLP awareness, professional and technical ability training is essential, so GLP institutions in the education and training of personnel throughout the entire career. Through summarizing the existing problems and the importance of training in GLP institutions, this paper compares and discusses the training classification, training requirements and the status quo at home and abroad so as to show that only practical and effective training can help GLP institutions to cultivate Qualified and qualified staff to enable staff to have the correct laws and regulations and GLP awareness, solid professional knowledge, proficiency in operational skills, excellent team awareness, in order to fundamentally improve the quality of pre-clinical safety evaluation of drugs and promote the rapid development of GLP institutions.