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1、电大药事管理与法规形成性考核册作业答案没有找到全的药事管理与法规作业1一、 名词解释P2、P6、P6、P6、P71.药品：药品是指预防、治疗、诊断人的疾病，有目的地调节人的生理功能并规定有适应证或者功能主治、用法用量的物质，包括中药材、中药饮片、中成药、化学原料及其制剂、生化药、放射要、血液药品及诊断药品等。1. 药事：药事可以理解为一切与药有关的事物：也是药学事业的首称。它是由若干个药学部门构成一个完整体系，包括药学教育、药学研发、注册、生产、经营、使用、监督等。2. 药事管理：宏观只通过国家立法，政府通过实行相关法律法规保证公众用药安全、有效、合理、方便、及时 微观药事组织依法通过实行相关
2、管理措施，对自身药事活动进行管理，以取得社会效益3. 药事法规：由国家制定或认可，并由国家强制力保证实施。并有普遍效力和严格程序的行为规范体系，是调整和保护公民在药事活动中，为维护人生命健康权益而形成各种社会关系和法律规范总和4. 药事管理学科：是药学科学的一个分支学科，是一门综合学科，以药学为基础，用药学、法学、管理学、经济学等学科的基本理论与方法对药事及药理活动研讨与探究，找到科学方法对药事及药理进行有效监督，保证药品使用安全、有效、确保国家人力、财力投入配置合理，以取得良好的经济效益，使药品达到预防、治疗疾病的目的，保证及提高人的健康水平。二、 选择F、E、C、J、G、I、D、H、A、B
3、、三、 简答P3-5、P13、P251.答：从药学历史角度分类：现代药及传统药 从药品使用途径及安全角度分类：处方药、非处方药 从国家对药品注册管理角度分类：新药、仿制药、医疗机构制剂 从药品社会价值及社会功能角度分类：国家基本药物、国家储备药物、基本医疗保险用药和特殊管理药2.答：1、制定药品、医疗器械等安全监督管理政策、规划并监督实施、参与起草相关法律法规和部门规章制度 2、负责药品医疗器械行政监督与技术监督，负责制定药品和医疗器械研制、生产、流通、使用方面的质量管理并监督实施 3、负责药品、医疗器械注册和监督管理，拟定国家药品标准并实施：开展药品不良反应及医疗器械不良事件监测，负责药品医
4、疗器械评价及淘汰，参与制定国家药物基本目录，配合有关部门实施国家基本药物制度，组织实施处方药及非处方药分类管理 4、负责制定中药、民族药规范并实施、拟定标准制定中药及饮片使用规范，实施中药保护制度 5、监督药品及医疗器械、放射药、麻醉药、毒性药的质量安全信息 6、查处药品、医疗器械、化妆品等的研制、生产、流通、使用等方面的违法行为 7、指导地方药品有关方面的监督管理、应急、稽查和信息化建设工作 8、拟定并完善执业药师资格准入制度，指导监督执业药师注册工作 9、开展与食品药品监督管理有关的国际交流合作3.答：行政复议机关对争议的具体行为接受复议申请、进行审理、作出裁决的行政行为。 行政诉讼是由人
5、民法院依据事实与法律对行政争议的案件进行审理并作出裁决的活动四、 论述P97、P231.答：药品管理法第47条规定：生产、销售假药的没收违法财产、销售药品及违法所得，并处违法生产、销售药品的货值金额2倍以上5倍以下罚款。有药批文件的予以撤销，责令停产，情节严重的吊销“药品生产许可证”或“医疗机构制许可证”，构成犯罪的依法追究刑事责任 药品管理法第75条规定：生产、销售假药的没收违法财产、销售药品及违法所得，并处违法停产、销售药品的货值金额1倍以上3倍以下罚款。情节严重责令停产、整顿或撤销药批文件，吊销生产、经营许可证，或制剂许可证。构成犯罪的依法追究刑事责任2.答：就出具虚假检验报告这一违法行
6、为：产品质量法与药品管理法发色红娘沟冲突，关于特别法优于普通法的原则：适于药品管理法而不是产品管理法，如果药品质量法未能对某一事项进行适用，在产品管理法有相关条款能够予以适用时，适用产品质量法药事管理与法规作业2一、 名词解释P30、P34、P37、P56、P62二、选择A、 B、C、D、E、F、J、H、G、I三、简答无解、P32、P46四、论述P53、P39药事管理与法规作业3一、名词解释P64、P103、P103、P90、P117二、选择J、F、I、A、D、C、B、E、H、G三、简答P85、P89、P93四、论述P66(1)-(4)、P99药事管理与法规作业4一、名词解释P138、P148
7、、P141、P148、P142二、选择G、I、E、C、H、D、J、B、A、F三、简答P126、P128、P135-137四、论述P133、P131药事管理与法规作业5一、名词解释P166、P179、P169、P184、P190二、选择B、A、G、D、E、F、J、I、C、H三、简答P167、P173P176、P186-P187四、论述P173P176、P193请您删除一下内容，O(_)O谢谢！2015年中央电大期末复习考试小抄大全，电大期末考试必备小抄，电大考试必过小抄Shanghais Suzhou Creek has witnessed much of the citys history.
8、Zhou Wenting travels this storied body of water and finds its most fascinating spots. Some lucky cities can boast a great body of water, like London with the river Thames and Paris with the river Seine. Shanghai is privileged enough to have two great bodies of water: Huangpu River and Suzhou Creek.H
9、uangpu River became famous when colonists established clusters of grand buildings on its banks on what became known as the bund. Today, the bund overlooks the breathtaking skyline of Lujiazui financial district. Shanghais other body of water, however, Suzhou Creek, has been somewhat overshadowed. Su
10、zhou Creek links the inland cities of Jiangsu province with Shanghai. When the British colonists, who arrived in the city after it was opened as a commercial port in 1843 found they could reach Suzhou, Jiangsu province, via the creek, they named it Suzhou Creek. Thanks to its location, a large amoun
11、t of cargo and travelers were transported via the creek before rail links were established. But after a century of being utilized as a waterway to transport goods and labor, the creek grew dark and smelly. Industrial factories were established along the banks. In the 1990s it became a key task of th
12、e city government to clean the creek. Suzhou Creek, which snakes 17 km from the iconic Waibaidu Bridge downtown to the outer ring road in west Shanghai, maps the changing periods of the citys history, including the imprints of the concessions, the beginning of industrialization and the improvement i
13、n peoples living conditions. Where the Bund began In-between the shopping street of East Nanjing Road and the Bund, are a cluster of streets that give me the illusion that I am no longer in modern Shanghai. The streets are narrow and old and criss-cross each other. Any old residential house may turn
14、 out to be a former office of the British, constructed in the 1880s. Pawnshops and hardware stores that are hard to find elsewhere, are plentiful here. This area, at the confluence of Huangpu River and Suzhou Creek, is called the Bund Origin. Countless tour buses stop at the site every day and visit
15、ors from around the world get off to see this place, the starting point of the concessions in the city. It all started in 1872, when the former British Consulate General was constructed and the Bund began its transformation into an the financial street of the East. Now the site of the former consulate is called “No 1 Waitanyuan”, which translates to “the Bund Origin”, to honor its beginnings. The entire complex of this historical site comprises of five buildings, the former British Consulate General, the official
