2020年电大药事管理与法规形成性考核册答案

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精选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、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-可编辑修改-

1精选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一、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-可编辑修改-

2精选三、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-可编辑修改-

3精选请您删除一下内容，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’sSuzhouCreekhaswitnessedmuchofthecity’shistory.ZhouWentingtravelsthisstoriedbodyofwaterandfindsitsmostfascinatingspots.Someluckycitiescanboastagreatbodyofwater,likeLondonwiththeriverThamesandPariswiththeriverSeine.Shanghaiisprivilegedenoughtohavetwogreatbodiesofwater:HuangpuRiverandSuzhouCreek.HuangpuRiverbecamefamouswhencolonistsestablishedclustersofgrandbuildingsonitsbanksonwhatbecameknownasthebund.Today,thebundoverlooksthebreathtakingskylineofLujiazuifinancialdistrict.Shanghai’sotherbodyofwater,however,SuzhouCreek,hasbeensomewhatovershadowed.SuzhouCreeklinkstheinlandcitiesofJiangsuprovincewithShanghai.WhentheBritishcolonists,whoarrivedinthecityafteritwasopenedasacommercialportin1843foundtheycouldreachSuzhou,Jiangsuprovince,viathecreek,theynameditSuzhouCreek.Thankstoitslocation,alargeamountofcargoandtravelersweretransportedviathecreekbeforeraillinkswereestablished.Butafteracenturyofbeingutilizedasawaterwaytotransportgoodsandlabor,thecreekgrewdarkandsmelly.Industrialfactorieswereestablishedalongthebanks.Inthe1990sitbecameakeytaskofthecitygovernmenttocleanthecreek.SuzhouCreek,whichsnakes17kmfromtheiconicWaibaiduBridgedowntowntotheouterringroadinwestShanghai,mapsthechangingperiodsofthecity’shistory,includingtheimprintsoftheconcessions,thebeginningofindustrializationandtheimprovementinpeople’slivingconditions.WheretheBundbeganIn-betweentheshoppingstreetofEastNanjingRoadandtheBund,areaclusterofstreetsthatgivemetheillusionthatIamnolongerinmodernShanghai.Thestreetsarenarrowandoldandcriss-crosseachother.AnyoldresidentialhousemayturnouttobeaformerofficeoftheBritish,constructedinthe1880s.Pawnshopsandhardwarestoresthatarehardtofindelsewhere,areplentifulhere.Thisarea,attheconfluenceofHuangpuRiverandSuzhouCreek,iscalledtheBundOrigin.Countlesstourbusesstopatthesiteeverydayandvisitorsfromaroundtheworldgetofftoseethisplace,thestartingpointoftheconcessionsinthecity.Itallstartedin1872,whentheformerBritishConsulateGeneralwasconstructedandtheBundbeganitstransformationintoanthefinancialstreetoftheEast.Nowthesiteoftheformerconsulateiscalled“No1Waitanyuan”,whichtranslatesto“theBundOrigin”,tohonoritsbeginnings.Theentirecomplexofthishistoricalsitecomprisesoffivebuildings,theformerBritishConsulateGeneral,theofficialresidenceoftheconsul,theformerUnionChurch,thechurchapartmentsandtheformerShanghaiRowingClub.Thesizeofthecourtyardisequivalenttothatoffourstandardsoccerfields.Thebuildingoftheformerconsulateisatwo-storeymasonrybuildingonanH-shapedplanintypicalEnglishrenaissance style.Thebuildingisdesignedwithafive-archverandahonthegroundfloorwitharaisedterracefacingthegarden,whilethefacadefeaturesanentryporticobeneathacolonnadedloggia.Ithasbeenturnedintoacaféwheredinnerandafternoon tea areavailable.Visitorscanchoosetositindoorsoroutdoorstoenjoythemagnificentgardenswithnearly30ancienttrees.YuanmingyuanRoadbehindthecomplexisalsoahistoricalsite.Theroadhasbeenrevampedasapedestrianshoppingstreetandhigh-endbrandshaveseizedthebestspots.Altogether,14oldbuildings,includingthoseusedforofficesandresidencesconstructedduring1920sand1930s,remain.Today,itisapopularlocationforcommercial fashion photoshoots.NewTian’anChurch,orUnionChurch,standsattheintersectionofYuanmingyuanRoadandSuzhouCreek.Thechurch,designedinthestyleoftheEnglishcountryside,hasacapacityof500people.Itwasverypopularduringtheconcessionperiodbutwasconvertedintofactoryofficesafter1949.Thechurchweseetodayisareplica,theoriginalburneddownin2007.Thereusedtobeanoutdoorswimmingpool,thefirstofitskindinShanghai,besidethechurchbuthasbeenfilled-inandisnowasmallgarden.BridgeofromanceThereisperhapsnootherplacethat’smorerepresentativeofShanghaithanthisbridge,whichappearsinquitealotof moviesaboutthecity.Dozensofcouplesvisiteverydaytoposefortheirpre-weddingphotosonthebridgewhereSuzhouCreekbeginsandinterconnectswithHuangpuRiver.ThisisWaibaiduBridge,ortheGardenBridge.Thesoon-to-be-wedcouplesposeinsplendidattireonthebridge,leaningagainsttherailingorsittingonthewoodenfloor.Someevenriskwalkingintothemiddleoftheroadtogettheperfectshot.Colorfullightsilluminatethebridgethroughoutthenight,makingitapicturesqueplaceforpre-weddingportraitsandloverstomeet.Constructedin1873anddesignedbyaBritishcompany,the106-meter-longbridgewasthefirst-evermajorbridgeinShanghai.In1856,thefirstlargewoodenbridge,WellsBridge,wasbuiltoverSuzhouCreekbutthebridgetollledtocomplaintsfromcitizens.So17yearslater,anotherwoodenbridge,whichdidnotrequiretolls,wasbuilt.PeoplecalleditWaibaidu,whichmeans“goingacrossforfree”.Thebridgewasrenovatedasasteeltrussstructurein1907.Becausenearly40bridgeshavenowbeenbuiltoverSuzhouCreek,thebridgeisnolongeratrafficarterybutismoreofanobservationdeckfortourists.ItisatraditioninShanghaiforagrandmothertowalkacrossabridgewiththeirgrandchildwhenheorshereachesonemonth.Thisrepresentsthatthenewbornhasovercomeallthetwistsandturnsanditsjourneywillbesafeandsmooththroughouthisorherlife."WaibaiduBridgeisalwaysthebestoptionbecauseit’stheiconofShanghai.Thepictureofmydaughterwhenshewasababyheldbyhergrandmotherwasalsotakenhere.It’slikeafamilytradition,"saysWangXuefen,aShanghainativewhohasanewborngrandson.ChangningRiversideThereisa5-kmstretchofwaterfrontbySuzhouCreekinChangningdistrictonChangningRoadfromtheintersectionofHamiRoadtoJiangsuRoad.Ithasbecomeapopularplacetotakeawalkandsunbatheonthelawn.ThereisanoverpassattheintersectionofChangningRoadandGubeiRoadforpeopletoenjoytheviewofthecreekanda3-kmplasticrunwayonbothsidesofChangningRoad,whichattractspeopleofallages,Chineseandexpat."Joggingonthetwosidesgivesadifferentfeelingbecausethenorthsideisnexttothecreek,andthesouthsideisadjacenttotheresidentialhighrises,whichislikejogginginthejungle,"saysXiaoXu,a27-year-oldwomanwholivesnearby.Theriversideusedtobecompletelydifferent.Dozensoftextilemills,chemicalplantsandmachinemanufacturingfactoriesweresetupalongthecreekinthe1920s.Theybroughtindustrializationbutalsopollution.Fromthe1930sthecreekcouldnolongerbeusedasasourcefortapwater,andnolivingfishorshrimpcouldbefound."SuzhouCreekinmymemoryisdarkandsmelly.IusedtogototheriverbanktowatchthesewagedisposalrunningoutfromthechemicalplantswhenIwasalittlegirl.Wedidn’tknowitwaspollution.Wethoughtitwasaredwaterfall,"saysHuangQi,a57-year-oldShanghairesident."Sotheresidentialhousesalongthecreekwereunpopular,andonlymigrantswithlowincomeswouldliveinthatarea,"shesays.However,thingshavechanged.Theplantswereclosedandturnedintoriversideparksandthe-可编辑修改-

4精选apartmentsinthenewhighrises,especiallythosefacingthecreek,aremuchsoughtafter.EastChinaUniversityofPoliticalScienceandLawThisisthefamousformerSaintJohn’sUniversity,China’sfirst-evermoderninstitutionofhighereducationestablishedbymissionariesfromtheUnitedStatesin1879.ThebuildingscombineChineseandWesternelements.Address:1575WanhangduRoad,ChangningdistrictTheoldresidentialareaAfteryouleavetheuniversityfromitseastgateyouwillenterashabbyneighborhoodthatretainsitsoriginallook.Thealleysarenarrowandthehousesareovercrowded.Somethingshavenotchangedformanygenerations,suchasraisingchickensathome.Address:WestGuangfuRoadMoganshanRoadThisisan artsystreetthathasbecomeverypopularamongartistsandfashionistasinrecentyears.Graffiticoversthewallsonthewindingstreet,whereyoucanfindaclusterofartgalleriesandcreativeindustryoffices.SihangWarehouse Fourbanksjointlyfundedtheconstructionofthiswarehouse,soitisnamedsihang,orfourbanks.Thewarehouse,builtin1931,wasusedforthestorageoffood,first-aidsuppliesandammunitionduringtheyearsofwar.Thebuilding,whichisalsoamasterpieceleftbytheHungarianarchitectLaszloHudecinthe1930s,hasbeenrecentlytransformedintoacenterofcreativeindustryworkshops.Address:1GuangfuRoad,Zhabeidistrict资料可以编辑修改使用资料可以编辑修改使用资料可以编辑修改使用-可编辑修改-

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