2015电大药事管理与法规形成性考核册答案

电大药事管理与法规形成性考核册作业答案

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药事管理与法规作业1

一、名词解释

P2、P6、P6、P6、P7

1.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、

三、简答

P3-5、P13、P25

1.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、P23

1.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、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Shanghai’s Suzhou Creek has witnessed much of the city’s history. 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.Huangpu 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. Shanghai’s other body o f water, however, Suzhou Creek, has been somewhat overshadowed. Suzhou 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 amount 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 the 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 city’s history, including the imprints of the concessions, the beginning of industrialization and the improvement in people’s 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 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

visitors 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 residence of the consul, the former Union Church, the church apartments and the former Shanghai Rowing Club. The size of the courtyard is equivalent to that of four standard soccer fields. The building of the former consulate is a two-storey masonry building on an H-shaped plan in typical English renaissance style. The building is designed with a five-arch verandah on the ground floor with a raised terrace facing the garden, while the facade features an entry portico beneath a colonnaded loggia. It has been turned into a café where dinner and afternoon tea are available. Visitors can choose to sit indoors or outdoors to enjoy the magnificent gardens with nearly 30 ancient trees. Yuanmingyuan Road behind the complex is also a historical site. The road has been revamped as a pedestrian shopping street and high-end brands have seized the best spots. Altogether, 14 old buildings, including those used for offices and residences constructed during 1920s and 1930s, remain. Today, it is a popular location for commercial fashion photo shoots.New Tian’an Church, or Union Church, stands at the intersection of Yuanmingyuan Road and Suzhou Creek. The church, designed in the style of the English countryside, has a capacity of 500 people. It was very popular during the concession period but was converted into factory offices after 1949. The church we see today is a replica, the original burned down in 2007. There used to be an outdoor swimming pool, the first of its kind in Shanghai, beside the church but has been filled-in and is now a small garden. Bridge of romance There is perhaps no other place that’s more representative of Shanghai than this bridge, which appears in quite a lot of movies about the city. Dozens of couples visit every day to pose for their pre-wedding photos on the bridge where Suzhou Creek begins and interconnects with Huangpu River. This is Waibaidu Bridge, or the Garden Bridge. The soon-to-be-wed couples pose in splendid attire on the bridge, leaning against the railing or sitting on the wooden floor. Some even risk walking into the middle of the road to get the perfect shot.Colorful lights illuminate the bridge throughout the night, making it a picturesque place for pre-wedding portraits and lovers to meet. Constructed in 1873 and designed by a British

company, the 106-meter-long bridge was the first-ever major bridge in Shanghai. In 1856, the first large wooden

bridge, Wells Bridge, was built over Suzhou Creek but the bridge toll led to complaints from citizens. So 17 years

later, another wooden bridge, which did not require tolls,

was built. People called it Waibaidu, which means “going

across for free”. The bridge was renovated as a steel truss

structure in 1907. Because nearly 40 bridges have now

been built over Suzhou Creek, the bridge is no longer a traffic

artery but is more of an observation deck for tourists. It is a

tradition in Shanghai for a grandmother to walk across a

bridge with their grandchild when he or she reaches one

month. This represents that the newborn has overcome all

the twists and turns and its journey will be safe and smooth

throughout his or her life. "Waibaidu Bridge is always

the best option because it’s the icon of Shanghai. The picture

of my daughter when she was a baby held by her grandmother was also taken here. It’s like a family tradition," says Wang Xuefen, a Shanghai native who has a newborn grandson. Changning Riverside There is a 5-km stretch of waterfront by Suzhou Creek in Changning district on Changning Road from the intersection of Hami Road to Jiangsu Road. It has become a popular place to take a walk and sunbathe on the lawn. There is an overpass at the intersection of Changning Road and Gubei Road for people to enjoy the view of the creek and a

3-km plastic runway on both sides of Changning Road, which attracts people of all ages, Chinese and expat. "Jogging on the two sides gives a different feeling because the north side is next to the creek, and the south side is adjacent to the residential highrises, which is like jogging in the jungle," says Xiao Xu, a 27-year-old woman who lives nearby. The riverside used to be completely different. Dozens of textile mills, chemical plants and machine manufacturing factories were set up along the creek in the 1920s. They brought industrialization but also pollution. From the 1930s the creek could no longer be used as a source for tap water, and no living fish or shrimp could be found. "Suzhou Creek in my memory is dark and smelly. I used to go to the riverbank to watch the sewage disp osal running out from the chemical plants when I was a little girl. We didn’t know it was pollution. We thought it was a red waterfall," says Huang Qi, a 57-year-old Shanghai resident. "So the residential houses along the creek were unpopular, and only migrants with low incomes would live in that area," she says. However, things have changed. The plants were closed and turned into riverside parks and the apartments in the new highrises, especially those facing the creek, are much sought after. East China University of Political Science and Law This is the famous former Saint John’s University, China’s first-ever modern institution of higher education established by missionaries from the United States in 1879. The buildings combine Chinese and Western elements. Address: 1575 Wanhangdu Road, Changning district The old residential area After you leave the university from its east gate you will enter a shabby neighborhood that retains its original look. The alleys are narrow and the houses are overcrowded. Some things have not changed for many generations, such as raising chickens at home. Address: West Guangfu Road Moganshan Road This is an artsy street that has become very popular among artists and fashionistas in recent years. Graffiti covers the walls on the winding street, where you can find a cluster of art galleries and creative industry offices. Sihang Warehouse Four banks jointly funded the construction of this warehouse, so it is named sihang, or four banks. The warehouse, built in 1931, was used for the storage of food, first-aid supplies and ammunition during the years of war. The building, which is also a masterpiece left by the Hungarian architect Laszlo Hudec in the 1930s, has been recently transformed into a center of creative industry workshops. Address: 1 Guangfu Road, Zhabei district