浙江省2004年10月高等教育自学考试 药事管理学及法规试题 课程代码03034

发布时间:   来源:文档文库   
字号:
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to law, standardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction浙江省200410月高等教育自学考试
药事管理学及法规试题
课程代码:03034 本试卷分AB卷,使用第2版教材的考生请做A卷,使用第3版教材的考生请做B卷;若AB两卷都做的,以B卷记分。
A
一、名词解释(每小题5分,共20 1.药品标准 2.ADR 3.新药 4.医疗机构制剂
二、判断题(判断下列各题,正确的在题后括号内打“√”,错的打“╳”。每小题2分,10
1.我国的传统药包括蒙药、藏药。( 2.药师就是执业药师。(

3.药品质量监督检验在法律上具有仲裁性。( 4.国家药品监督管理局负责批准进口药品广告。(

5.擅自经营精神药品,根据情节轻重可能被处以罚款、停业整顿、吊销许可证等行政处罚。(

三、单项选择题(在每小题的四个备选答案中,选出一个正确答案,并将正确答案的序号填在题干的括号内。每小题1分,共15 1.《中华人民共和国药品管理法》属于( A.法律 C.法规 A.人参 C.藏红花 3.海洛因属于( A.麻醉药品 C.戒毒药品







B.精神药品 D.医疗用毒性药品






B.规章 D.以上三者都不是 B.梅花鹿茸 D.雪莲
2.以下属于国家二级保护野生药材物种的是(
4.第一类精神药品(
A.每张处方不得超过2日常用量 B.每张处方不得超过3日常用量 C.每张处方不得超过5日常用量 D.每张处方不得超过7日常用量
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. o conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX powegeneration companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to lawstandardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction5.我国对上市五年以内的药品,药品不良反应的报告范围是( 不良反应。 A.严重 C.可疑的 A.GAP C.GLP (
A.处方药 C.乙类非处方药 8.外用药品应使用( A.蓝白标志 C.绿白标志





B.红白标志 D.黑白标志

B.甲类非处方药 D.基本医疗保险甲类目录药品






B.罕见 D.所有可疑 B.GSP
D.GCP 6.药品经营质量管理规范的英文简写为(
7.不需处方即可自行判断、购买、使用,必须在具有《药品经营许可证》的药店零售的为9.药品零售企业的购进记录(
A.保存至超过药品有效期1年,但不得少于3 B.保存至超过药品有效期1年,但不得少于2 C.应保存5 D.应保存3
10.考察在广泛使用条件下的药物的疗效和不良反应的为( A.临床前研究 C.Ⅱ期临床试验 11.待发药品库用( 色标。 A.黄色 C.绿色 A.仲裁性 C.评价性







B.橙色 D.白色
B.抽查性 D.技术性

B.I期临床试验 D.Ⅳ期临床试验
12.药品质量监督检验的法律性质为(
13.负责全国药品不良反应监测的技术业务组织工作的是( A.SFDA药品认证中心 B.国家药典委员会 C.SFDA药品评价中心 D.SFDA药品审评中心
14.医药机构应当依法向( 提供其药品的实际购销价格和购销数量等资料。 A.药品监督管理部门 C.价格管理部门

B.卫生行政部门 D.工商行政管理部门
15.国家药监局决定批准已有国家药品标准的药品生产(
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. o conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX powegeneration companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to law, standardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction A.以《药品临床研究批件》的形式 B.以《药品注册批件》的形式 C.以《药品补充申请批件》的形式 D.以《进口药品注册证》的形式 四、多项选择题(在每小题的五个备选答案中,选出二至五个正确的答案,并将正确答案的序号分别填在题干的括号内,多选、少选、错选均不得分。每小题2分,共20 1.以下属于我国药品标准的是( A.中国药典 C.药品卫生标准 E.中国医院制剂规范
2.属于国家检定的品种有( A.有质量问题的药品 C.首次在中国销售的药品 E.国务院规定的其他药品
3.地方人民政府和药品监督管理部门不得有下列哪些行为?(

A.以要求实施药品检验限制非本地区药品生产企业依照本法规定生产的药品进入本地区 B.以要求实施药品审批等手段排斥非本地区药品生产企业依照本法规定生产的药品进入本地区
C.不得参与药品生产经营活动
D.采取停止生产、销售、使用的紧急控制措施 E.以其名义推荐或者监制、监销药品
4.国家对药品不良反应实行( 报告制度。 A.越级 D.定期

B.快速 E.随时
C.逐级
B.存在质量争议的药品 D.SFDA规定的生物制品

B.中国生物制品规程 D.省级炮制规范

5.需要由国务院药品监督管理部门负责GMP认证工作的为( 药品生产企业。 A.注射剂 B.放射性药品 C.国务院药品监督管理部门规定的生物制品 D.新增中药制剂

E.以上均是
6.应当经国务院药品监督管理部门审查批准的有( A.某种药物非临床试验 B.某种药物临床试验 C.某种药品的生产 D.某种药品的经营 E.某种药品的进口
7.药品监督管理部门设置的派出机构,有权作出《药品管理法》及其条例规定( 行政处罚。
A.警告 C.没收违法生产、销售的药品

B.罚款

D.没收违法所得

03034# 药事管理学及法规试题
3 8
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. To conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX power generation companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to lawstandardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership constructionE.拘留
8.药品广告管理中,需要将药品广告批准文号向( 备案。 A.药品生产企业所在地省、自治区、直辖市人民政府药品监督管理部门 B.进口药品代理机构所在地省、自治区、直辖市人民政府药品监督管理部门 C.药品进口地省、自治区、直辖市人民政府药品监督管理部门 D.广告发布地省、自治区、直辖市人民政府药品监督管理部门 E.国务院药品监督管理部门
9.国家药品监督管理局对下列新药申请可以实行快速审批( A.新的中药材及其制剂

B.未在国内外获准上市的化学原料药及其制剂、生物制品
C.抗艾滋病病毒及用于诊断、预防艾滋病的新药,治疗恶性肿瘤、罕见病等的新药 D.治疗尚无有效治疗手段的疾病的新药 E.从中药、天然药物中提取的有效成份及其制剂 10.医疗机构配置制剂,必须有(
A.处方 B.配置规程 C.标准操作规程 D.批生产记录 E.生产工艺规程
五、简答题(每小题10分,共20 1.简述药品专利的类型。 2.简述药品监督管理的主要职能。 六、论述题(15
根据药品管理法的规定,论述生产销售劣药的法律责任。
B
一、单项选择题(在每小题的四个备选答案中,选出一个正确答案,并将正确答案的序号填在题干的括号内。每小题2分,共40 1.在美国,非处方药被称为( A.P C.GSL medicines







B.GP
D.OTC 2.纳入《国家基本医疗保险药品目录》的药品,应符合以下原则( A.临床必需、安全有效、价格合理、使用方便、保证供应 B.临床必需、安全有效、价格合理、保障供应、中西药并重 C.临床必需、安全有效、价格合理、保障供应、使用方便 D.临床必需、安全有效、质量稳定、保证供应、中西药并重
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. o conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX powegeneration companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to law, standardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction 3.属于国家一级保护的野生药材物种是( A.龙胆 C.麝香 4.咖啡因属于( A.麻醉药品 C.戒毒药品 A.派出机构 C.分支机构





B.精神药品 D.医疗用毒性药品 B.直属机构 D.垂直机构






B.熊胆 D.豹骨
5.县级药品监督管理机构为上一级药品监督管理机构的(
6.负责修订国家药品标准的是( A.国务院药品监督管理部门药品认证中心 B.国家药典委员会
C.国家中药品种保护审评委员会
D.国务院药品监督管理部门药品审评中心
7.某销售假药者,已售假药150万元,库存药品50万元,处以二倍罚款,则罚款金额为(
A.200万元 C.300万元







B.100万元 D.400万元
8.药品监督管理部门依法对有证据证明可能危害人体健康的药品及其有关证据材料采取查封、扣押的行政强制措施的,应当自采取行政强制措施之日起( 日内作出是否立案的决定。 A.5 C.10









B.7
D.15 B.规格 D.给药途径
9.非处方药分为甲类、乙类的根据是( A.剂型 C.安全性

10.由于药物本身的药理作用增强而发生的不良反应属于WHO( 不良反应。 A.A类不良反应 B.B类不良反应 C.药物相互作用引起的 D.迟现型 11.药物临床试验质量管理规范简称( A.GCP C.GLP







B.GMP
D.GSP 12.下列哪一项说法是错误的?(

A.新药技术转让后,国家药品监督管理局对于转让方已取得的药品批准文号,予以保留
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. To conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX power generation companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!03034# 药事管理学及法规试题
5 8

We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to lawstandardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership constructionB.国家药品监督管理局和省、自治区、直辖市药品监督管理局不受理依据试行标准提出的已有国家标准的药品注册申请
C.监测期内的药品,不得进行新药技术转让
D.接受新药技术转让的药品生产企业必须取得《药品生产许可证》和《GMP》认证证书 13.进口药品分包装按( 办理。 A.新药申请 C.已有国家标准药品的申请

B.进口药品申请 D.补充申请
14.以下属于已有国家标准的中药批准文号的是( A.ZZ2002国药准字ZF B.国药准字ZF C.国药试字ZF D.国药准字Z 15.GMP规定,洁净室的照度一般应为( A.100Lux C.300Lux









B.150Lux
D.350Lux B.10000级洁净室( D.洁净室(
16.不得设置地漏,操作人员不应裸手操作,当不可避免时,手部应及时消毒的是( A.100级洁净室( C.100000级以上区域 17.药品生产的物料储存期(
A.至药品有效期后1年,至少保存3 B.至药品有效期后1年,至少保存2 C.保存3 D.一般不超过3 18.经营乙类非处方药的药品零售企业,应当配备( A.执业药师
B.经市级药品监督管理部门考核合格的业务人员 C.依法经资格认定的药学技术人员 D.药品质量管理人员
19.药品生产企业不得委托生产的药品为( A.注射剂






B.放射性药品 D.疫苗
B.中医君臣佐使原则 D.药物酸碱度规律
C.中药饮片

20.按照相关规定,中药说明书中,中药复方制剂主要药味的排序要符合( A.笔画多少顺序 C.药性寒凉温热顺序

二、多项选择题(在每小题的五个备选答案中,选出二至五个正确的答案,并将正确答案的序号分别填在题干的括号内,多选、少选、错选均不得分。每小题2分,共10 21.在销售前或进口时,由国务院药品监督管理部门指定的药品检验机构进行检验的药品(
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. o conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX powegeneration companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!
We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to law, standardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction A.国务院药品监督管理部门规定的生物制品 B.首次在中国销售的药品 C.存在质量争议的药品
D.国务院药品监督管理部门规定的其他药品 E.国务院规定的其他药品
22.以下属于假药的是( A.未标明有效期或者更改有效期的 B.超过有效期的 C.变质的

D.所标明的适应症或者功能主治超出规定范围的 E.药品所含成份与国家药品标准规定的成份不符的
23.药品监督管理部门设置的派出机构,有权作出《药品管理法》及其条例规定的行政处(
A.警告 B.罚款 C.没收违法生产、销售的药品 D.没收违法所得 E.吊销许可证
24.以下对于二级保护野生药材物种表述正确的是( A.资源处于衰竭状态 B.不得使用禁用工具采猎 C.不得在禁猎期采猎 D.不得出口 E.必须按照批准的计划采猎
25.经销进口药品,必须出具( A.药品经营许可证 B.加盖公章的进口药品注册证复印件
C.签字盖章的药品进口合同复印件 D.加盖公章的口岸药检所的药品检验报告书复印件 E.销售人员的身份证
三、判断题(判断下列各题,正确的在题后括号内打“√”,错的打“╳”。每小题2分,10
26.我国药品管理法中的药事不包括药品的研制。( 27.所有的戒毒药品都按处方药管理。(

28.国家药品监督管理局对药品监督管理系统实行垂直管理。( 29.处方药可以采用纪实文学的方式在《浙江日报》上宣传。( 30.执业药师对本单位的违法行为,有权拒绝执行并向上级汇报。( 四、名词解释(每小题4分,共16
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. To conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX power generation companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!03034# 药事管理学及法规试题
7 8

We will continue to improve the company's internal control system, and steady improvement in ability to manage and control, optimize business processes, to ensure smooth processes, responsibilities in place; to further strengthen internal controls, play a control post independent oversight role of evaluation complying with third-party responsibility; to actively make use of internal audit tools detect potential management, streamline, standardize related transactions, strengthening operations in accordance with law. Deepening the information management to ensure full communication "zero resistance". o constantly perfect ERPand BFS++, and PI, and MIS, and SCM, information system based construction, full integration information system, achieved information resources shared; to expand Portal system application of breadth and depth, play information system on enterprise of Assistant role; to perfect daily run maintenance operation of records, promotproblem reasons analysis and system handover; to strengthening BFS++, and ERP, and SCM, technology application of training, improve employees application information system of capacity and level. Humanistic care to ensure "zero." To strengthening Humanities care, continues to foster company wind clear, and gas are, and heart Shun of culture atmosphere; strengthening love helped trapped, care difficult employees; carried out style activities, rich employees life; strengthening health and labour protection, organization career health medical, control career against; continues to implementation psychological warning prevention system, training employees health of character, and stable of mood and enterprising of attitude, created friendly fraternity of Humanities environment. To strengthen risk management, ensure that the business of "zero risk". To strengthened business plans management, will business business plans cover to all level, ensure the business can control in control; to close concern financial, and coal electric linkage, and energy-saving scheduling, national policy trends, strengthening track, active should; to implementation State-owned assets method, further specification business financial management; to perfect risk tube control system, achieved risk recognition, and measure, and assessment, and report, and control feedback of closed ring management, improve risk prevention capacity. o further standardize trading, and strive to achieve "according to lawstandardize and fair." Innovation of performance management, to ensure that potential employees "zero fly". To strengthen performance management, process control, enhance employee evaluation and levels of effective communication to improve performance management. To further quantify and refine employee standards ... Work, full play party, and branch, and members in "five type Enterprise" construction in the of core role, and fightingfortress role and pioneer model role; to continues to strengthening "four good" leadership construction31.非处方药 32.麻醉药品 33.药品批发企业 34.执业药师
五、简答题(每小题6分,共12 35.简述《药品管理法》中药品的概念。
36.试列举出《药品流通监督管理办法》中至少六种药品无证经营的情形。 六、论述题(12
37.结合我国对药品广告监督管理的主要规定,联系实际,试分析我国目前药品广告中存在的问题。
lay levels cadres in enterprise development in the of backbone backbone role; to full strengthening members youth work, full play youth employees in company development in the of force role; to improve independent Commission against corruption work level, strengthening on enterprise business key link of effectiveness monitored. , And maintain stability. To further strengthen publicity and education, improve the overall legal system. We must strengthen safety management, establish and improve the education, supervision, and evaluation as one of the traffic safety management mechanism. o conscientiously sum up the Olympic security controls, promoting integrated management to a higher level, higher standards, a higher level of development. Employees, today is lunar calendar on December 24, the ox Bell is about to ring, at this time of year, we clearly feel the pulse of the XX power generation company to flourish, to more clearly hear XX powegeneration companies mature and symmetry breathing. Recalling past one another across a railing, we are enthusiastic and full of confidence. Future development opportunities, we more exciting fight more spirited. Employees, let us together across 2013 full of challenges and opportunities, to create a green, low-cost operation, full of humane care of a world-class power generation company and work hard! The occasion of the Spring Festival, my sincere wish that you and the families of the staff in the new year, good health, happy, happy!

本文来源:https://www.2haoxitong.net/k/doc/d1794db43868011ca300a6c30c2259010202f39f.html

《浙江省2004年10月高等教育自学考试 药事管理学及法规试题 课程代码03034.doc》
将本文的Word文档下载到电脑,方便收藏和打印
推荐度:
点击下载文档

文档为doc格式