电大药事管理与法规形成性考核册答案.doc

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11、 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。2、 选择F、E、C、J、G、I、D、H、A、B、3、 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4、 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21、 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请您务必删除一下内容，O(_)O万分谢谢！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Indonesia has emerged as a top vacation destination for Chinese this summer, along with Thailands Phuket island and the Maldives archipelago. Encouraged by growth in Chinese travelers to Indonesia, the government in Jakarta has recently relaxed its visa policy. Since June 10, Chinese tourists can enter Indonesia through nine appointed locations, including the Soekarno Hatta International Airport in Jakarta, the Ngurah Rai International Airport in Bali and the Kuala Namu International Airport in Medan, by just getting their passports stamped on arrival. Officially, it is called the free-visa scheme. The new policy also means Chinese tourists can save $35 on visa fees, which will likely make trips to Indonesia more alluring. While such an arrangement allows Chinese visitors to stay up to 30 days for the purpose of traveling, those seeking extensions will need to get paid visas from that countrys missions inBeijing,Shanghai,GuangzhouorHong Kong, according to an official at the Indonesia embassy in Beijing. Santo Darmosumarto, head of the embassys information, social and cultural section, says the new policy is aimed at strengthening people-to-people contacts between the two countries. Dai Yu, marketing director of Ctrip, a major Chinese online travel agency, says: Weve seen a nearly 50 percent growth over the previous month in the number of Chinese tourists to Bali since the policy was announced. During his trip to China in March, Indonesian President Joko Widodo proposed that his country and China aim to increase two-way visits to a maximum of 10 million people in the next few years. The Indonesian government has set their sights on greeting 2 million Chinese tourists by the end of this year, according to the official. The Indonesian government hopes that Indonesian nationals would also be given preferential treatment while visiting China, says Darmosumarto. In 2013, the number of Chinese tourists who visited Indonesia stood around 807,000. Last year, it increased to 959,000, he adds. Bali remains the most popular site among Chinese tourists. In February, more than 92,200 Chinese tourists made trips to Bali, ranking first among overseas visitors, the Bali Times reported. Last year, the island witnessed more than 586,000 arrivals from China, an increase of 51 percent over 2013. Bali isnt just for sightseeing, but also for weddings, honeymoons, golf and many outdoor activities, says Fan Wenqing, a marketing executive at Garuda, Indonesias national airliner. Garuda offers three nonstop flights between Beijing and Bali, and four each week between Beijing and Jakarta. There are daily flights from Guangzhou, inGuangdongprovince, and Shanghai to Jakarta as well. It takes from six to eight hours on a nonstop flight to reach Indonesia from China. Indonesia is home to more than 17,000 islands. Tourists can tour Yogyakarta to see Prambanam and Borobudur, two historical and religious sites, and explore the local handicraft markets. The base of a volcano, Bandung, which is also known as the Paris of Java, is ideal for adventure-seekers. Many ecotourism destinations, such as Toba Lake in Sumatra, Tanjung Puting National Park in Kalimantan and Bunaken in Manado, are places the embassy official recommends for tourists. Indonesia boasts world-class surfing facilities along the shores of Sumatra down to Nusa Tenggara Islands. Recently, Lombok, a sister island east of Bali has gotten so much attention from Chinese travelers that some travel agencies are offering twin packages for Bali and Lombok. The best time to visit Bali is from May to October, when it doesntrainmuch and the weather is cool. At press time, a weeklong package from Shanghai or Guangzhou to Bali was a little more than 3,000 yuan ($480) on Ctrips website. Chinese tourists have taken a shine to rafting in Ubud, sightseeing in Tanah Lot, and surfing and diving in Nusa Lembongan, says Dai. Civet coffee, essential oil and woodcarvings are among the most popular products for Chinese tourists in Indonesia, she says. Indonesian food is also something that visitors shouldnt miss. Local cuisines feature many spices, including peppers and cloves, and coconut pulp. Fried rice, dirty duck and roast suckling pig are recommended. Childrens illustration books first appeared in the 1600s in Europe. Their passage to China, however, took much longer, roughly 300 years. In China, childrens illustration books have a history of just 100 years and their development can be divided into four stages. From early 1900s to mid 1900s, a large number of books and magazines with illustrations appeared with the fast development of the modern publishing industry. The illustrationarts at that time were a mixed genre of Chinese traditionalpaintings and the westernstyle, and most of the stories originate from the fundamental changes that China experienced after the collapse of Qing Dynasty (1644-1911), the warlord struggles and the war against the Japanese invasion. The second stage was from mid 1900s to late 1970s, when the cultural revolution (1966-76) ended. The fast development of some special publishing houses for children gave birth to a large number of illustration-story books, which made a good use of folk art techniques, such as wood board carving, frescoes, and ink and wash painting, etc. Many of the popular stories are from Chinese history and wars after 1900s. The third stage is from early 1980s to late 1990s, a golden period for the development of childrens illustration books. The reform and opening-up brought in new concepts and ideas from the West to China, a country that had been closed to the West for nearly three decades. Fast development of economy, society and culture provided the writers and painters with a lot of inspiration to create new literature works and draw illustrations. China also imported large amounts of childrens illustration books from the West and Japan. Many young parents in China have a strong nostalgia about childrens illustration books they read in the 1980s and 1990s. This is also the last era in Chinas artistic innovation before the advent of the Internet period. The fourth stage is featured with the spread of the Internet and the other computerized means of art innovation. The hand-drawn childrens illustration books are gradually replaced by cartoons drawn and copied by software and machines, and shown on tablets, computers, television and smart phones, instead of books. Hainan Tropical Wildlife Park and Botanical Garden is natures haven, with no less than 4,000 rare birds and animals representing 200 species. With tropical forest covering over 90 percent of its area, the garden offers beautiful views of a wide range of tropical plants, flowers and fruit trees. The scenic spot about 25 kilometers from the center of Haikou offers a drive-thru safari tour where you can get up close with elephants, lions and bears. The Safari on Foot area features walking trails where visitors can see the rest of the animals, including hippos and monkeys, and feed them for a small fee. Visitors also can see what happens when you breed a lion and a tiger. Two unique attractions are rare hybrids: a liger, the offspring of a mallion and a female tiger and a tigon, which is created by a female lion and a male tiger. As ateaching center of the National Popular Science Education program, the park also serves as a second classroom for students to learn about wildlife and plants. Since it was established in 1995, it has received more than one million student visitors. At a crucial moment when pessimism has brought the Greek crisis to such a head that the country is closer to a default on its debt repayments than ever, Li offered a spark of enthusiasm to restart the stalled talks by calling on Greece and its creditors to reach a last-minute deal that will allow Greece to remain in the eurozone. Given the escalation of the countrys crisis over the weekend sent a shock wave through the global stock markets on Monday, there are ample reasons to worry about the uncertainties surrounding the events in Greece and the effect a default would have on Europe, relations between China and the EU, global financial stability and the nascent global economic recovery. Greece has announced that it will hold a referendum on a bailout plan proposed last week by the countrys creditors. In response, Greeces eurozone partners have refused to extend the countrys bailout program and the European Central Bank capped its emergency support for the countrys banks. A real danger now looms of Greece exiting the euro, which might derail the global economic recovery and damage the long-term viability of the euro as a currency. However, such a tragedy is neither certain nor unavoidable. The EU should shoulder its responsibility to prevent the Greek crisis from overshadowing the fragile global recovery. As a major customer and supplier of the 28-nation EU, and a responsible long-term holder of Eurobonds, Chinas confidence in and commitment to a strong eurozone offers EU leaders the necessary support to look at the Greek crisis from a broader and longer perspective. When Li said that China will not only consider a China-EU investment platform to back European Commission President Jean-Claude Junckers plan to revive the European economy, but also buy more bonds issued by the European Investment Bank, EU leaders should be clear that China wants to see the EU maintain its integrity and a forward trajectory. Such a confidence-building effort is particularly valuable, especially from such a large country as China which already has a huge stake and seeks to further expand it in a strong eurozone. It will be a tragedy to allow inaction over the Greek crisis to stand in the way of growth-boosting Sino-EU cooperation.请您务必删除一下内容，O(_)O万分谢谢！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Indonesia has emerged as a top vacation destination for Chinese this summer, along with Thailands Phuket island and the Maldives archipelago. Encouraged by growth in Chinese travelers to Indonesia, the government in Jakarta has recently relaxed its visa policy. Since June 10, Chinese tourists can enter Indonesia through nine appointed locations, including the Soekarno Hatta International Airport in Jakarta, the Ngurah Rai International Airport in Bali and the Kuala Namu International Airport in Medan, by just getting their passports stamped on arrival. Officially, it is called the free-visa scheme. The new policy also means Chinese tourists can save $35 on visa fees, which will likely make trips to Indonesia more alluring. While such an arrangement allows Chinese visitors to stay up to 30 days for the purpose of traveling, those seeking extensions will need to get paid visas from that countrys missions inBeijing,Shanghai,GuangzhouorHong Kong, according to an official at the Indonesia embassy in Beijing. Santo Darmosumarto, head of the embassys information, social and cultural section, says the new policy is aimed at strengthening people-to-people contacts between the two countries. Dai Yu, marketing director of Ctrip, a major Chinese online travel agency, says: Weve seen a nearly 50 percent growth over the previous month in the number of Chinese tourists to Bali since the policy was announced. During his trip to China in March, Indonesian President Joko Widodo proposed that his country and China aim to increase two-way visits to a maximum of 10 million people in the next few years. The Indonesian government has set their sights on greeting 2 million Chinese tourists by the end of this year, according to the official. The Indonesian government hopes that Indonesian nationals would also be given preferential treatment while visiting China, says Darmosumarto. In 2013, the number of Chinese tourists who visited Indonesia stood around 807,000. Last year, it increased to 959,000, he adds. Bali remains the most popular site among Chinese tourists. In February, more than 92,200 Chinese tourists made trips to Bali, ranking first among overseas visitors, the Bali Times reported. Last year, the island witnessed more than 586,000 arrivals from China, an increase of 51 percent over 2013. Bali isnt just for sightseeing, but also for weddings, honeymoons, golf and many outdoor activities, says Fan Wenqing, a marketing executive at Garuda, Indonesias national airliner. Garuda offers three nonstop flights between Beijing and Bali, and four each week between Beijing and Jakarta. There are daily flights from Guangzhou, inGuangdongprovince, and Shanghai to Jakarta as well. It takes from six to eight hours on a nonstop flight to reach Indonesia from China. Indonesia is home to more than 17,000 islands. Tourists can tour Yogyakarta to see Prambanam and Borobudur, two historical and religious sites, and explore the local handicraft markets. The base of a volcano, Bandung, which is also known as the Paris of Java, is ideal for adventure-seekers. Many ecotourism destinations, such as Toba Lake in Sumatra, Tanjung Puting National Park in Kalimantan and Bunaken in Manado, are places the embassy official recommends for tourists. Indonesia boasts world-class surfing facilities along the shores of Sumatra down to Nusa Tenggara Islands. Recently, Lombok, a sister island east of Bali has gotten so much attention from Chinese travelers that some travel agencies are offering twin packages for Bali and Lombok. The best time to visit Bali is from May to October, when it doesntrainmuch and the weather is cool. At press time, a weeklong package from Shanghai or Guangzhou to Bali was a little more than 3,000 yuan ($480) on Ctrips website. Chinese tourists have taken a shine to rafting in Ubud, sightseeing in Tanah Lot, and surfing and diving in Nusa Lembongan, says Dai. Civet coffee, essential oil and woodcarvings are among the most popular products for Chinese tourists in Indonesia, she says. Indonesian food is also something that visitors shouldnt miss. Local cuisines feature many spices, including peppers and cloves, and coconut pulp. Fried rice, dirty duck and roast suckling pig are recommended. Childrens illustration books first appeared in the 1600s in Europe. Their passage to China, however, took much longer, roughly 300 years. In China, childrens illustration books have a history of just 100 years and their development can be divided into four stages. From early 1900s to mid 1900s, a large number of books and magazines with illustrations appeared with the fast development of the modern publishing industry. The illustrationarts at that time were a mixed genre of Chinese traditionalpaintings and the westernstyle, and most of the stories originate from the fundamental changes that China experienced after the collapse of Qing Dynasty (1644-1911), the warlord struggles and the war against the Japanese invasion. The second stage was from mid 1900s to late 1970s, when the cultural revolution (1966-76) ended. The fast development of some special publishing houses for children gave birth to a large number of illustration-story books, which made a good use of folk art techniques, such as wood board carving, frescoes, and ink and wash painting, etc. Many of the popular stories are from Chinese history and wars after 1900s. The third stage is from early 1980s to late 1990s, a golden period for the development of childrens illustration books. The reform and opening-up brought in new concepts and ideas from the West to China, a country that had been closed to the West for nearly three decades. Fast development of economy, society and culture provided the writers and painters with a lot of inspiration