与委托方的有效沟通在GLP试验中的重要性

发布时间：2018-07-30 07:08

【摘要】：GLP行业作为近20年来发展起来的医药外包服务行业,在积极提升机构科研人员业务水平和机构管理水平的同时,想要为国内外用户提供高质量的科研服务、顺利完成药物安全性评价试验,与委托方的沟通也显得尤为重要,不能忽视。由于委托单位无论是药厂还是一般的研发机构,他们对于GLP领域的国家法规和药物安全性评价的专业技术并不是非常的了解,因此,在合同签订的初期,被委托机构要耐心的向委托方进行讲解,对于比较大的项目最好是进行面对面的沟通,使他们了解GLP方面的一些法规和要求,使他们了解到整个试验安排以及他们在这个过程中需要做什么,包括他们提供的供试品和对照品的一些要求,提供多少量的供试品和对照品,提供什么形式的供试品和对照品,哪些供试品信息是必须提供的等等,这些都有助于试验的按期顺利开展;在试验进行的过程中,被委托机构也应该主动的将阶段性的试验结果和进展及时汇报给委托方,以便委托方对药物研发计划进行调整,提高药物研发的效率。在这整个过程中,被委托机构应该作为一个主体来促进沟通有效的进行,提高科研服务的质量。
[Abstract]:As a pharmaceutical outsourcing service industry developed in the past 20 years, GLP industry wants to provide high quality scientific research services to domestic and foreign users while actively promoting the level of business and management of scientific research personnel in institutions. The successful completion of drug safety evaluation test, communication with the client is particularly important, can not be ignored. As the entrustment units, whether they are pharmaceutical factories or general R & D institutions, are not very familiar with the national regulations in the field of GLP and the expertise in drug safety evaluation, therefore, in the early stages of the contract, The entrusted organization should be patient to explain to the entrustment. For larger projects, it is best to communicate face to face so that they can understand some of the regulations and requirements of the GLP. To make them aware of the whole experiment arrangement and what they need to do in the process, including some of the requirements for the test and reference substances they provide, how many tests and standards will be provided and in what form they will be offered, Which information on the test items must be provided, and so on, all of which contribute to the smooth progress of the trials on schedule; during the course of the trials, the entrusted agencies should also take the initiative to report the results and progress of the periodic trials to the entrusting parties in a timely manner. In order for the client to adjust the drug development plan, improve the efficiency of drug development. In the whole process, the entrusted institution should act as a main body to promote effective communication and improve the quality of scientific research services.
【作者单位】：广州中医药大学科技产业园(新南方药物安全性评价中心);
【基金】：广东省科技计划项目(2012B010300003)
【分类号】：F426.72;F719;R95

【相似文献】