2018電大藥事管理與法規(guī)形成性考核冊答案

電大復(fù)習資料電大藥事管理與法規(guī)形成性考核冊作業(yè)答案沒有找到全的 藥事管理與法規(guī)作業(yè) 11、名詞解釋P2、P6、P6、 P6、P71.藥品：藥品是指預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理功能并規(guī)定有適應(yīng)證或者功能主治、用法用量的物質(zhì)，包括中藥材、中藥飲片、中成藥、化學原料及其制劑、生化藥、放射要、血液藥品及診斷藥品等。1.藥事：藥事可以理解為一切與藥有關(guān)的事物：也是藥學事業(yè)的首稱。它是由若干個藥學部門構(gòu)成一個完整體系，包括藥學教育、藥學研發(fā)、注冊、生產(chǎn)、經(jīng)營、使用、監(jiān)督等。2.藥事管理：宏觀只通過國家立法，政府通過實行相關(guān)法律法規(guī)保證公眾用藥安全、有效、合理、方便、及時微觀藥事組織依法通過實行相關(guān)管理措施，對自身藥事活動進行管理，以取得社會效益3.藥事法規(guī)：由國家制定或認可，并由國家強制力保證實施。并有普遍效力和嚴格程序的行為規(guī)范體系，是調(diào)整和保護公民在藥事活動中，為維護人生命健康權(quán)益而形成各種社會關(guān)系和法律規(guī)范總和4.藥事管理學科：是藥學科學的一個分支學科，是一門綜合學科，以藥學為基礎(chǔ)，用藥學、法學、管理學、經(jīng)濟學等學科的基本理論與方法對藥事及藥理活動研討與探究，找到科學方法對藥事及藥理進行有效監(jiān)督，保證藥品使用安全、有效、確保國家人力、財力投入配置合理，以取得良好的經(jīng)濟效益，使藥品達到預(yù)防、治療疾病的目的，保證及提高人的健康水平。2、選擇F、E、 C、J、G、I 、D、H、 A、B、3、簡答P3-5、P13 、P251.答：從藥學歷史角度分類：現(xiàn)代藥及傳統(tǒng)藥從藥品使用途徑及安全角度分類：處方藥、非處方藥從國家對藥品注冊管理角度分類：新藥、仿制藥、醫(yī)療機構(gòu)制劑從藥品社會價值及社會功能角度分類：國家基本藥物、國家儲備藥物、基本醫(yī)療保險用藥和特殊管理藥2.答：1、制定藥品、醫(yī)療器械等安全監(jiān)督管理政策、規(guī)劃并監(jiān)督實施、參與起草相關(guān)法律法規(guī)和部門規(guī)章制度2、負責藥品醫(yī)療器械行政監(jiān)督與技術(shù)監(jiān)督，負責制定藥品和醫(yī)療器械研制、生產(chǎn)、流通、使用方面的質(zhì)量管理并監(jiān)督實施3、負責藥品、醫(yī)療器械注冊和監(jiān)督管理，擬定國家藥品標準并實施：開展藥品不良反應(yīng)及醫(yī)療器械不良事件監(jiān)測，負責藥品醫(yī)療器械評價及淘汰，參與制定國家藥物基本目錄，配合有關(guān)部門實施國家基本藥物制度，組織實施處方藥及非處方藥分類管理4、負責制定中藥、民族藥規(guī)范并實施、擬定標準制定中藥及飲片使用規(guī)范，實施中藥保護制度5、監(jiān)督藥品及醫(yī)療器械、放射藥、麻醉藥、毒性藥的質(zhì)量安全信息6、查處藥品、醫(yī)療器械、化妝品等的研制、生產(chǎn)、流通、使用等方面的違法行為7、指導地方藥品有關(guān)方面的監(jiān)督管理、應(yīng)急、稽查和信息化建設(shè)工作8、擬定并完善執(zhí)業(yè)藥師資格準入制度，指導監(jiān)督執(zhí)業(yè)藥師注冊工作9、開展與食品藥品監(jiān)督管理有關(guān)的國際交流合作電大復(fù)習資料3.答：行政復(fù)議機關(guān)對爭議的具體行為接受復(fù)議申請、進行審理、作出裁決的行政行為。行政訴訟是由人民法院依據(jù)事實與法律對行政爭議的案件進行審理并作出裁決的活動4、論述P97、P231.答：藥品管理法第 47 條規(guī)定：生產(chǎn)、銷售假藥的沒收違法財產(chǎn)、銷售藥品及違法所得，并處違法生產(chǎn)、銷售藥品的貨值金額 2 倍以上 5 倍以下罰款。有藥批文件的予以撤銷，責令停產(chǎn)，情節(jié)嚴重的吊銷“藥品生產(chǎn)許可證”或“醫(yī)療機構(gòu)制許可證” ，構(gòu)成犯罪的依法追究刑事責任藥品管理法第 75 條規(guī)定：生產(chǎn)、銷售假藥的沒收違法財產(chǎn)、銷售藥品及違法所得，并處違法停產(chǎn)、銷售藥品的貨值金額 1 倍以上 3 倍以下罰款。情節(jié)嚴重責令停產(chǎn)、整頓或撤銷藥批文件，吊銷生產(chǎn)、經(jīng)營許可證，或制劑許可證。構(gòu)成犯罪的依法追究刑事責任2.答：就出具虛假檢驗報告這一違法行為：產(chǎn)品質(zhì)量法與藥品管理法發(fā)色紅娘溝沖突，關(guān)于特別法優(yōu)于普通法的原則：適于藥品管理法而不是產(chǎn)品管理法 ，如果藥品質(zhì)量法未能對某一事項進行適用，在產(chǎn)品管理法有相關(guān)條款能夠予以適用時，適用產(chǎn)品質(zhì)量法藥事管理與法規(guī)作業(yè) 21、名詞解釋P30、P34、P37 、P56、P62二、選擇A、B、C 、D、E、F 、J、H、G 、I三、簡答無解、P32、P46四、論述P53、P39藥事管理與法規(guī)作業(yè) 3一、名詞解釋P64、P103、P103 、P90、P117二、選擇J、F、I、A、D 、C 、B、E、H 、G三、簡答P85、P89、P93四、論述P66(1)-(4)、P99藥事管理與法規(guī)作業(yè) 4一、名詞解釋P138、P148、P141 、P148、P142二、選擇電大復(fù)習資料G、I、E 、C 、H、D、J、B、A 、F三、簡答P126、P128、P135-137四、論述P133、P131藥事管理與法規(guī)作業(yè) 5一、名詞解釋P166、P179、P169 、P184、P190二、選擇B、A、G、D、E、F、J 、I 、 C、H三、簡答P167、P173P176、P186-P187四、論述P173P176、P193電大復(fù)習資料請您刪除一下內(nèi)容，O(_)O 謝謝！ 2015 年中央電大期末復(fù)習考試小抄大全，電大期末考試必備小抄，電大考試必過小抄 Shanghais Suzhou Creek has witnessed much of the citys 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. Shanghais other body of 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 citys history, including the imprints of the concessions, the beginning of industrialization and the improvement in 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 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 caf 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 Tianan 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 thats 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 its the icon of Shanghai. The picture of my daughter when she was a baby held by her grandmother was also taken here. Its 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 disposal running out from the chemical plants when I was a little girl. We didnt 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 Johns University, Chinas first-ever modern institution of higher education established by missionaries from the United States in 1