用创新思维推进食品药品监管信息化建设

食品药品监管的信息化和现代化建设是社会进步、科技发展的必然产物和必然趋势,也是落实科学发展观和国家信息化发展战略的重要体现。食品药品监管的信息化,就是运用现代信息技术、基础平台、网络环境和信息资源,推进信息技术资源与食品药品监管资源的一体融合,实现监管需求实时可知,行为规范实时可视,日常管理实时可控。通过信息化建设,不仅能够加快推进食品药品监管系统现代化建设步伐,而且还能够弥补食品药品监管工作中因监管对象点多线长、监管力量薄弱出现的监管盲区多、监管周期长、监管质量下降等不利因素。一、创新思路,搭建信息化…     

浅谈医疗器械注册审评信息数据的整合

各级食品药品监督管理部门围绕职能均建立了计算机业务操作系统,如何对其运行过程中产生的数据信息进行整合和资源共享,是当前信息化工作面临的重要课题。本文即以国家食品药品监督管理局层面负责承担的国产三类和进口医疗器械产品注册审评工作中产生的审评数据为例,尝试对医疗器械注册审评信息数据及其数据中心进行定义,并对当前医疗器械注册审评信息数据的质量和利用现状、数据整合的必要性进行了分析。结合注册审评工作实际,提出医疗器械注册审评数据整合的具体实施方法,以期为下一步建设食品药品(医疗器械)监管数据中心做好医疗器械注册审评信息数据整合方面的前期基础性工作。     

浅谈大数据时代食品药品监管数据资源的综合管理

随着互联网和信息技术的不断发展,各行各业对数据的应用愈加重视,数据资源的重要价值随之突显;国家层面也陆续出台相关文件,对数据管理提出相应要求。本文通过问题和现状分析,着重研究探讨在食品药品监管系统内如何针对数据资源开展共建共享和统筹管理,以期能够为相关工作提供参考。     

强化监管服务体系建设 确保公众饮食用药安全

解决好当前新形势下食品药品监管面临的难题,需要进一步解放思想,转变观念,切实加强和完善基层食品药品监管和服务体系建设,不断创新食品药品监管方式方法,不断提升管理服务水平。强化基层监管和服务体系是新形势下的新要求当前,食品药品安全各种矛盾集中凸显,表面上是食品药品保障的现状与人们的需求差距之间的矛盾加大造成,认真分析成因,     

浅谈食品药品监管工作信息化建设

目的为加快食品药品监管工作信息化建设,提高食品药品信息化监管水平提供建议。方法分析食品药品监管工作信息化建设的现状和存在的问题。结果与结论提升对信息化工作的认识,加强日常监管,做好应用系统建设和整合,实现资源共享,从而提升食品药品监管水平和监管实效。     

以建设药品品种档案为例探讨主数据管理在药品监管领域的应用

目的：探索研究主数据管理在药品监管领域的应用。方法：介绍主数据及主数据管理相关概念，以药品品种档案为例，提出通过主数据管理思路来建设药品品种档案系统的原理、方法和建议。结果与结论：采用主数据管理思路建设药品品种档案是一种可行方案，通过主数据的分发和共享能够确保不同系统间的数据标准化和一致性，从而促进药品品种档案信息的整合和共享。在我国药品监管信息化建设中，应大力推广主数据管理。     

我国食品药品安全精准监管实施路径研究

目的：探索我国食品药品安全监管的粗放式监管方式,向精准化监管转变的制度设计和实施路径。方法：采用文献回顾和数据分析方法,分析我国食品药品安全管理制度及其分类和分级监管措施,探索监管资源配置现状及精准监管的设计思路。结果与结论：当前,我国食品药品监管存在监管人员缺口较大、监管力量相对薄弱的问题。食品药品安全精准监管设计思路应从企业产品分类分级、信息化大数据和基层分类分级的三维度考虑;精准监管实施路径,包括加大监管资源投入力度、属地统筹协调、综合治理网格化管理、政府购买服务、强化大数据分析等。     

建立和完善食品药品监管系统教育培训体系的思路

人的因素是影响食品药品安全的根本因素.提升从业人员的职业素质和监管人员的执法水平是改善食品药品安全状况的关键.因此,优先建立和完善食品药品监管系统教育培训体系,大力加强教育培训工作至关重要.1 食品药品监管系统教育培训体系的现状和问题食品药品监管系统组建以来,教育培训工作成绩显著,人才队伍建设取得了长足发展,教育培训体系建设取得了一定进步.     

食品药品监管培训课程课程标准的建设

摘 要 目的：为了提高食品药品监管系统培训的规范性、统一性和实效性,使食品药品监管人员更快地适应新体制,更好地履行新职能。方法: 通过比较教学大纲和课程标准的区别,分析食品药品监管队伍现状、培训现状,发现监管系统的培训现状、培训需求与课程标准的特点有很高的契合度。结果: 通过比较,发现课程标准更加适合食品药品监管队伍教育培训。结论:有必要逐步加强食品药品监管系统教育培训课程标准的建设。     

全国食品药品监督管理暨党风廉政建设工作会议在京召开

本刊讯2013年1月10日至11日上午,全国食品药品监督管理暨党风廉政建设工作会议在京召开。会议总结了2012年食品药品监管工作,分析了当前和今后一段时间监管形势,部署了2013年食品药品监管工作和党风廉政建设任务,表彰了全国食品药品监管系统先进集体和先进工作者。会议提出,要解放思想、改革创新,同心协力、攻坚克难,切实保障人     

Computerized Management of Clinical Trials and Patient Data: The Clinical Data Manager

Abstract

Microcomputer technology and database management software are beginning to be utilized in the management of clinical trials and patient data. the Clinical Data Manager? (CDM), is a database management system (DBMS) developed at Harvard University School of Public Health and enhanced by Clinical Data. CDM automates certain tasks associated with the management of clinical trials including enrollment, monitoring of protocol compliance, adverse reaction reporting, results validation, data analysis, and FDA submissions. the placing of microcomputers at local sites to accomplish data entry and reporting facilitates protocol implementation, and enhances trial management. the prime benefits of distributed data management include the accelerated approval and the documentation of the risks and benefits of new drugs and devices.     

Data Mining and Statistically Guided Clinical Review of Adverse Event Data in Clinical Trials

Some approaches to the analysis of adverse event data arising from clinical trials are presented. These include (a) an inside-out data mining method where the adverse events are used as explanatory variables, classifying the treatment allocation, (b) a support method where we fit separate regression models to each adverse event with and without a treatment effect, and (c) a three-level hierarchical Bayesian mixture model for analysis of adverse event counts. The problem of understanding treatment-emergence of the adverse events is formulated as one of data mining rather than hypothesis testing. Our approaches provide an ordering of the adverse events by the strength of evidence of a treatment effect, rather than p values for prespecified hypotheses. The three methods produce intuitive graphical summaries showing the treatment effect on adverse event incidence. These graphs can be readily linked to relevant supportive information such as reports summarizing predicted risks for (demographic) subpopulations of interest and patient-level data such as laboratory information, concomitant medications, and medical history. This results in a statistically guided and thorough review of drug safety in the clinical trial.     

Radiation Hormesis: Data and Interpretations

Although the biological effects of large doses of ionizing radiation are predominantly harmful, low-to-intermediate doses have been observed to enhance growth and survival, augment the immune response, and increase resistance to the mutagenic and clastogenic effects of further irradiation in plants, bacteria, insects, and mammals. The existence of these stimulatory, or “adaptive”, responses implies that the dose-response relationships for genetic and carcinogenic effects of radiation may be similarly biphasic, or hormetic, in nature, a possibility with far-reaching implications for radiation protection. As yet, however, the extent to which such responses may actually reduce the risks attributable to low-level irradiation remains to be determined, pending further elucidation of the relevant dose-response relationships and the apparent lack of responsiveness in some individuals. Therefore, further research is needed to resolve this question.     

利用DBCom bo控件实现数据输入的查阅向导

在 VB5 .0数据库编程中 ,应用数据绑定组合框控件 (DBCombo)可实现数据输入的查阅向导 ,即实现数据选项录入 ,提高数据录入效率和准确性     

Prediction of Human Bioavailability from Human Oral Administration Data and Animal Pharmacokinetic Data Without Data from Intravenous Administration of Drugs in Humans

Purpose  To predict the absolute oral bioavailabilities (BAs) of drugs in humans without using pharmacokinetic data from intravenous administration in humans. Methods  The distribution volume of the terminal phase () in humans was predicted by three methods using animal pharmacokinetic data. Then, total body clearance (CL_tot) was calculated by multiplying the elimination rate constant and , and the BA was calculated as a ratio between CL_tot and oral clearance. The predicted and observed values were compared for 67 drugs for which pharmacokinetic data after intravenous administration in humans were available. Results  For , predicted values within twice the observed value were obtained for 72.1% of drugs by both methods Ia and Ib, respectively, in which only rat pharmacokinetic data were used. The corresponding percentage was 75.0% for method II, in which pharmacokinetic data from animals other than rats were used. For BA, predicted values within 1.3 times the observed values were obtained for 66.7% and 57.4% of drugs by methods Ia and Ib, respectively, and 75.0% by method II. Conclusions  Using the present methods, it is possible to predict BA from human oral administration data combined with animal pharmacokinetic data to a certain level without using intravenous injection data. Electronic supplementary material  The online version of this article (doi:) contains supplementary material, which is available to authorized users.