摘要
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。
The personnel is the most important and key point in Good Laboratory Practice （GLP） for non-clinical laboratory studies. The GLP awareness and professional and technical ability training is very important, so the education and training of personnel in GLP facilities should run through the whole career life. Based on the problems and importance for the personnel training, and compared with the training type, training requirements, and domestic and foreign status, it is clarified that only effective training may train qualified personnel for GLP facilities. The personnel with correct regulation idea and GLP awareness, solid professional knowledge, proficient operating skills, and excellent team spirit could fundamentally improve the rapid development of preclinical drug safety evaluation quality and GLP facilities.
出处
《药物评价研究》
CAS
2016年第4期510-512,共3页
Drug Evaluation Research
关键词
药物研究
非临床研究
安全性评价
评价质量
drug reasch
non-clinical laboratory studies
drug safety evaluation
evaluation quality
