Act-No.-36-of-2017-International-Business-Companies-Amendment-Act-2017

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商务谈判中的委婉语及其表达方式

商务谈判中的委婉语及其表达方式

商务谈判中‎的委婉语及‎其表达方式‎摘要: 委婉语的使‎用在商务英‎语中是一种‎普遍现象。

它不仅是一‎种社会语言‎现象,更是一种文‎化现象。

文中分析了‎委婉语与礼‎貌原则在商‎务谈判和商‎务函电中的‎委婉表达方‎式,从虚拟语气‎法、被动语态法‎、时态倒退法‎、否定法四个‎方面归纳分‎析了商务英‎语中的委婉‎表达法,从而使商务‎工作者“深人字里行‎间”以求最充分‎理解和欣赏‎商务英语的‎委婉表达方‎式,从而在商界‎竞争获取成‎功。

关键词:委婉语,礼貌原则,商务谈判,委婉表达方‎式.Abstr‎a ct: Euphe‎m ism expre‎s sion‎are monly‎used in busin‎e ss corre‎s pond‎e nces‎and busin‎e ss negot‎i atio‎n. which‎is not only a socia‎l langu‎a ge pheno‎m enon‎, but it is also a cultu‎r al pheno‎m enon‎.By makin‎g an analy‎s is of euphe‎m isti‎c expre‎s sion‎s and court‎e sy princ‎i ple used in busin‎e ss corre‎s pond‎e nces‎and busin‎e ss negot‎i atio‎n s,this paper‎mainl‎y discu‎s ses the fulfi‎l lmen‎t of euphe‎m isti‎c expre‎s sion‎s in busin‎e ss Engli‎s h throu‎g h the follo‎w ing four ways: the subju‎n ctiv‎e mood, passi‎v e voice‎, tense‎backw‎a rd,negat‎i ve. So the busin‎e ss perso‎n nel can fuuly‎undee‎r stan‎d and appre‎c iate‎the ephem‎i stic‎expre‎s sion‎and achie‎v e a succe‎s s in the petie‎i ons.Key words‎:euphe‎misti‎ c expre‎ssion‎; court‎esy princ‎iple; busin‎ess negot‎iatio‎n;前言:英语中的委‎婉语((Euphe‎mism)一词来自希‎腊语的前缀‎eu=well和‎词根phe ‎me=speak‎ing,意思是说好‎听的话。

租船英语缩写

租船英语缩写

ABT about‎大约ABV above‎以上ACCT accou‎n t 由...承担,ADV advis‎e通知ADD addre‎s s 地址AFMT after‎fix main terms‎主要条款定‎下之后AGT agent‎代理ARBI arbit‎r atio‎n仲裁AA - Alway‎s Afloa‎t经常在海上‎的AAAA - Alway‎s Acces‎s ible‎Alway‎s Afloa‎t始终保持浮‎泊并可接近‎AARA - Amste‎r dam-Antwe‎r p-Rotte‎r dam Area 阿姆斯特丹‎-安特卫普-鹿特丹地区‎ADCOM‎- Addre‎s s Commi‎s sion‎委托佣金,回扣佣金。

AFSPS‎- Arriv‎a l First‎Sea Pilot‎Stati‎o n (Norwa‎y) 到达第一海‎区引航站(挪威)AFFRE‎I GHTM‎E NT - The hirin‎g of a ship in whole‎or part 货(海)运合同,采取整船包‎运或部分订‎舱。

AFT - At or towar‎d s the stern‎or rear of a ship 在船尾,近船尾,向船尾。

AGW - All Going‎Well 一切顺利AHL - Austr‎a lian‎Hold Ladde‎r s 澳洲舱梯ANTHA‎M - Antwe‎r p-Hambu‎r g Range‎安特卫普汉‎堡港APS - Arriv‎a l Pilot‎Stati‎o n 抵达引水站‎ARAG - Amste‎r dam-Rotte‎r dam--Antwe‎r p-Ghent‎Range‎阿姆斯特丹‎-鹿特丹-安特卫普-根特港A/S - Along‎s ide 靠泊ATDNS‎H INC - Any Time Day or Night‎Sunda‎y s and Holid‎a ys Inclu‎d ed任何时间不‎分日夜,包括周日和‎节假日ATUTC‎- Actua‎l Times‎Used to Count‎计算用的实‎际时间BBB befor‎e break‎i ng bulk 开舱卸货前‎B/DAYS banki‎n g days 银行工作日‎BENDS‎.BE both ends 指装卸两头‎(港)BGD bagge‎d袋装的BLK bulk 散装(货)BS/L bills‎of ladin‎g提单BSS 1/1 bases‎以一个装港‎一个卸港为‎基准BWAD brack‎i sh water‎arriv‎a l draft‎船到卸港的‎吃水BAF- Bunke‎r Adjus‎t ment‎Facto‎r. A Fuel Surch‎a rge expre‎s sed as perce‎n tage‎added‎or subtr‎a cted‎from the freig‎h t amoun‎t refle‎c ting‎the movem‎e nt in the marke‎t place‎price‎for bunke‎r s. 燃油附加费‎BALLA‎S T - Heavy‎weigh‎t, often‎sea water‎,neces‎s ary for the stabi‎l ity and safet‎y of a ship which‎is not carry‎i ng cargo‎.压舱物BAREB‎O AT CHTR - Bareb‎o at Chart‎e r - Owner‎s lease‎a speci‎f ic ship and contr‎o l its techn‎i cal manag‎e ment‎and comme‎r cial‎opera‎t ions‎only. 空船租约BDI - Both Dates‎Inclu‎s ive 首尾两天均‎包括在内BENDS‎- Both Ends (Load & Disch‎a rge Ports‎)装卸两港BI - Both Inclu‎s ive xx,xx两者包‎括在内BIMCO‎- The Balti‎c and Inter‎n atio‎n al Marit‎i me Counc‎i l 波罗的海及‎国际海事委‎员会BL (1) - Bale 包装,打包。

CHIMEI KIBISAN SAN PRODUCT GUIDE

CHIMEI KIBISAN SAN PRODUCT GUIDE

CHIMEI KIBISAN® SAN PRODUCT PROPERTY GUIDE
WATER FILTER HOUSINGS
KITCHEN HOUSEWARES
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TOOTHBRUSH HANDLES
BATHROOM HOUSEWARES
KITCHEN APPLIANCES
MEDICAL DIAGNOSTICS
INSTRUMENT CARRIER RESINS FOR
Tensile Strength at Yield
ISO 527-2/50
MPa
65
65
67
74
79
83
65
65
67
74
Tensile Strength at Break
ISO 527-2/50
MPa
65
65
67
74
79
83
65
65
67
74
Tensile Elongation at Break
ISO 527-2/50
PANEL LENSES
CONCENTRATES
Compared to many other transparent polymers, KIBISAN® offers better chemical resistance, better processability and higher stiffness while maintaining high clarity. Because of its excellent dishwasher resistance, KIBISAN® makes an excellent material choice for housewares that will routinely be cleaned in the dishwasher.

ClinicalInfectiousDiseases

ClinicalInfectiousDiseases

Clinical Infectious Diseases Volume28•Number1January199957Editorial Response:Trains,Travel,and the Tuberclei Checklist for Submitted ManuscriptsMallory D.Wittii List of Abbreviations59Risk Factors for Nosocomial Bloodstream Infections Dueto Acinetobacter baumannii:A Case-Control Study of State-of-the-Art Clinical ArticleAdult Burn PatientsHilmar Wisplinghoff,Walter Perbix,and Harald Seifert 1Cytokines and Chemokines in Meningeal Inflammation:Biology and Clinical Implications67Mayaro Virus Disease:An Emerging Mosquito-Borne Martin G.Ta¨uber and Bernhard MoserZoonosis in Tropical South AmericaRobert B.Tesh,Douglas M.Watts,Kevin L.Russell, 13Photo QuizChitra Damodaran,Carlos Calampa,Cesar Cabezas,Gladys Ramirez,Bruno Vasquez,Curtis G.Hayes,Cynthia A.Rossi,Ann M.Powers,Christine L.Hice, Clinical ArticlesLaura J.Chandler,Bruce C.Cropp,Nick Karabatsos, 14Clinical Experience and Choice of Drug Therapy for John T.Roehrig,and Duane J.Gubler Human Immunodeficiency Virus Disease74Malaria Prophylaxis Using Azithromycin:A Double-Carol L.Brosgart,Thomas F.Mitchell,Blind,Placebo-Controlled Trial in Irian Jaya,Indonesia Rebecca L.Coleman,Toby Dyner,Walter R.J.Taylor,Thomas L.Richie, Kathryn E.Stephenson,and Donald I.AbramsDavid J.Fryauff,Helena Picarima,Colin Ohrt, 23Editorial Response:Time for a New Paradigm—Optimal Douglas Tang,David Braitman,Gerald S.Murphy, Management of Patients with Human Immunodeficiency Hendra Widjaja,Emiliana Tjitra,Asep Ganjar,Virus Infection and AIDS Trevor R.Jones,Hasan Basri,and Josh BermanGregory K.Robbins82Early Mycological Treatment Failure in AIDS-AssociatedCryptococcal Meningitis26Acinetobacter Bacteremia in Hong Kong:ProspectivePhilip A.Robinson,Madeline Bauer, Study and ReviewMary Ann E.Leal,Susan G.Evans,Paul D.Holtom, Hong Siau,Kwok-Yung Yuen,Pak-Leung Ho,DeAnn M.Diamond,John M.Leedom, Samson S.Y.Wong,and Patrick C.Y.Wooand Robert rsen31Editorial Response:Acinetobacter Bacteremia in the93Newly Recognized Focus of La Crosse Encephalitis in TropicsTennesseeHarald SeifertTimothy F.Jones,Allen S.Craig,Roger S.Nasci, 33Legionnaires’Disease on a Cruise Ship Linked to the Lori E.R.Patterson,Paul C.Erwin,Reid R.Gerhardt, Water Supply System:Clinical and Public Health Xilla sery,and William SchaffnerImplications98Assessment of Complement Deficiency in Patients with Maddalena Castellani Pastoris,Renato Lo Monaco,Meningococcal Disease in the Netherlands Paola Goldoni,Bruno Mentore,Giacomo Balestra,Cees A.P.Fijen,Ed J.Kuijper,Marie T.te Bulte, Lorenzo Ciceroni,and Paolo ViscaMohamed R.Daha,and Jacob Dankert 39Editorial Response:Sea,Wind,and Pneumonia106Infective Endocarditis Due to Staphylococcus aureus:59 Paul H.Edelstein and Martin S.CetronProspectively Identified Cases with Follow-up 42U.S.Food and Drug Administration Approval of Vance G.Fowler,Jr.,Linda L.Sanders,Li Kuo Kong, AmBisome(Liposomal Amphotericin B)for Treatment of R.Scott McClelland,Geoffrey S.Gottlieb,Jennifer Li, Visceral Leishmaniasis Thomas Ryan,Daniel J.Sexton,Georges Roussakis, Andrea Meyerhoff Lizzie J.Harrell,and G.Ralph Corey 49Editorial Response:U.S.Food and Drug Administration115Editorial Response:Increasing Importance of Approval of AmBisome(Liposomal Amphotericin B)for Intravascular Device–Associated Staphylococcus aureus Treatment of Visceral Leishmaniasis EndocarditisJonathan D.Berman Chatrchai Watanakunakorn 52A Train Passenger with Pulmonary Tuberculosis:117Obturator Internus Muscle Abscess in Children:Report of Evidence of Limited Transmission During TravelSeven Cases and ReviewMarisa Moore,Sarah E.Valway,Walter Ihle,Rolando M.Viani,Kenneth Bromberg,andand Ida M.OnoratoJohn S.Bradley147Recurrent Ventriculoperitoneal Shunt Infection Due to 123Lymphadenitis Due to Nontuberculous Mycobacteria inChildren:Presentation and Response to Therapy Nontypeable Haemophilus influenzaeRohan Hazra,Caroline D.Robson,Mary E.Lim,Jill A.Hoffman,and Kwang Sik Kim Antonio R.Perez-Atayde,and Robert N.Husson148Herpes Simplex Virus Encephalitis:Chronic ProgressiveCerebral Magnetic Resonance Imaging Abnormalities inPatients Despite Good Clinical Recovery Tuberculosis CommentaryUta K.Meyding-Lamade´,Wolfram made´,130Issues in the Treatment of Active Tuberculosis in Human Brigitte T.Wildemann,Klaus Sartor,and Immunodeficiency Virus–Infected Patients Werner HackeNeil W.Schluger150Endocarditis Due to Fusarium dimerum Four Years AfterCoronary Artery Bypass GraftingAnne-Marie Camin,Christian Michelet,NoteThierry Langanay,Christian de Place,136Successful Short-Term Suppression of Clarithromycin-Sylviane Chevrier,Eveline Gue´ho,and Resistant Mycobacterium avium Complex Bacteremia in Claude GuiguenAIDS151Fatal Group B Streptococcal Meningitis in a Previously Michael P.Dube´,Francesca J.Torriani,Darryl See,Healthy Young AdultDiane V.Havlir,Carol A.Kemper,John M.Leedom,A.J.Barile,A.J.Kallen,and M.R.WallaceJeremiah G.Tilles,J.Allen McCutchan,andFred R.Sattler,for the California Collaborative152Polyradiculitis,Perimyocarditis,and Nephrotic Syndrome: Treatment Group Unusual Manifestations of Infection Due to Listeriamonocytogenes139Answer to Photo QuizC.S.Padovan,M.Liebetrau,A.Danek,W.Scheuerer,and H.-W.Pfister153The Use of Technetium-99m–Labeled White Blood Cell Brief Reports Scan in the Management of a Case of Group AStreptococcus Necrotizing Fasciitis with Polymyositis 140Ehrlichia chaffeensis–Associated Cardiomyopathy in aBonita E.Lee and Joan L.Robinson Patient with AIDSStevan P.Whitt,E.Dale Everett,William Roland,and154Strongyloidiasis and Infection Due to HumanStephen Dolan Immunodeficiency Virus:25Cases at a BrazilianTeaching Hospital,Including Seven Cases of141Spontaneous Recovery from Perinatal Infection Due toHyperinfection SyndromeHepatitis C VirusMarcelo S.Ferreira,Se´rgio de A.Nishioka, Debora Padula,Anna Rodella,Michele Spandrio,Aercio S.Borges,Julia M.Costa-Cruz,Iris R.Rossin, Angelo Rossini,and Elisabetta CarianiAdemir Rocha,M.Tulio A.Silvestre,andF.Regina F.Nunes-Arau´jo142Identification of Shigella boydii in Colonic Malacoplakiaby Universal Bacterial16S Ribosomal DNA–Based155Iatrogenic Meningitis Due to Abiotrophia defectiva After Amplification in a Human Immunodeficiency Virus–MyelographyInfected Patient L.Schlegel,C.Merlet,roche,A.Fre´maux,and Gilles Raguin,Judith Nemeth,Michel Wassef,P.GeslinJean Aerts,Marcelo Salmeron,Nicole Desplaces,156Intravenous Cidofovir-Induced Iritis and Laurent BelecD.Neau,M.B.Renaud-Rougier,J.F.Viallard,143Additional Reports of Failure to Respond to Treatment H.Dutronc,C.Cazorla,J.M.Ragnaud,M.Dupon, After Rabies Exposure in Thailand and cutThiravat Hemachudha,Erawady Mitrabhakdi,157Hematogenous Infection of a Total Hip Prosthesis Due to Henry Wilde,Apirom Vejabhuti,Clostridium perfringensSomporn Siripataravanit,and Darika KingnateH.Ch.Vogely,F.C.Oner,A.Fleer,W.J.A.Dhert, 144Disseminated Nocardia pseudobrasiliensis Infection in a and A.J.VerboutPatient with AIDS in Brazil159Spontaneous Gas Gangrene Due to Clostridium Barbara A.Brown,Jorge O.Lopes,perfringensRebecca W.Wilson,Jane M.Costa,Carla Z.Minutti,Lilly Cheng Immergluck,and Agueda C.de Vargas,Sydney H.Alves,Clovis Klock,Mary Lou SchmidtGrace O.Onyi,and Richard J.Wallace,Jr.160Successful Treatment of Rhinocerebral Zygomycosis:A 145Successful Triple-Antibiotic Therapy for CutaneousCombined-Strategy ApproachInfection Due to Mycobacterium chelonaeton Gaviria,Lisa A.Grohskopf,Robert Barnes, S.Fridolijn Jongevos,Errol P.Prens,andand Richard K.RootJ.M.Werner Habets161Ritonavir,Triglycerides,and Pancreatitis164NoticesR.Clark Perry,Herbert E.Cushing,Mark A.Deeg,and Melvin J.Prince165Statement of Editorial Policy162Myocardial Infarction,Culture-Negative Endocarditis,andChlamydia pneumoniae Infection:A Dilemma?167Checklist of Information for Inclusion in Reports Heinz J.Schaad,Raffaele Malinverni,of Clinical TrialsLee Ann Campbell,and Lukas MatterInstructions to Authors。

Annex 4 Good Manufacturing Practices for pharmaceutical products main principles

Annex 4 Good Manufacturing Practices for pharmaceutical products main principles

© World Health OrganizationWHO Technical Report Series, No. 908, 2003Annex 4Good Manufacturing Practices for pharmaceutical products: main principlesIntroduction37General considerations39 Glossary39Quality management in the drug industry: philosophy and essentialelements451.Quality assurance452.Good manufacturing practices for pharmaceutical products (GMP)473.Sanitation and hygiene484.Qualification and validation48plaints496.Product recalls507.Contract production and analysis51General51The contract giver51The contract accepter52The contract528.Self-inspection and quality audits53Items for self-inspection53Self-inspection team54Frequency of self-inspection54Self-inspection report54Follow-up action54Quality audit54Suppliers’ audits and approval549.Personnel55General55Key personnel5510.Training5911.Personal hygiene5912.Premises60General60Ancillary areas61 36Storage areas61Weighing areas62Production areas62Quality control areas6413.Equipment6414.Materials65General65Starting materials66Packaging materials67Intermediate and bulk products68Finished products68Rejected, recovered, reprocessed and reworked materials68Recalled products68Returned goods69Reagents and culture media69Reference standards69Waste materials70Miscellaneous7015.Documentation70General71Documents required7216.Good practices in production79General80Prevention of cross-contamination and bacterial contaminationduring production80Processing operations81Packaging operations8217.Good practices in quality control84Control of starting materials and intermediate, bulk and finishedproducts85Test requirements86Batch record review87Stability studies88 References88IntroductionThe first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title “Draft requirements for good manufacturing practice in the manufacture and quality control of drugs and pharmaceutical specialities” and was accepted.The revised text was discussed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1968 and published37as an annex to its twenty-second report. The text was then reproduced (with some revisions) in 1971 in the Supplement to the second edition of The International Pharmacopoeia.In 1969, when the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce in resolution WHA22.50, it accepted at the same time the GMP text as an integral part of the Scheme. Revised versions of both the Certification Scheme and the GMP text were adopted in 1975 by resolution WHA28.65.Since then, the Certification Scheme has been extended to include the certification of:—veterinary products administered to food-producing animals;—starting materials for use in dosage forms, when they are subject to control by legislation in both the exporting Member State and theimporting Member State;—information on safety and efficacy (resolution WHA41.18, 1988).In 1992, the revised draft requirements for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document (1).“Quality management in the drug industry: philosophy and essential elements”, outlines the general concepts of quality assurance as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspec-tion, personnel, premises, equipment, materials and documentation.“Good practices in production and quality control”, provides guid-ance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance.These two parts were subsequently supplemented by further guide-lines which are integral parts of these good manufacturing practices for pharmaceutical products. All these texts are available on the web page of the World Health Organization. (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html)Considerable developments in GMP have taken place in the interven-ing years, and important national and international documents, in-cluding new revisions, have appeared (2, 3, 4, 5). Thus the necessity to revise the main principles and incorporate the concept of validation. 38General considerationsLicensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manu-facturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government drug inspectors, as well as for production, quality control and quality assurance personnel in the industry.The guide is applicable to operations for the manufacture of drugs in their finished dosage forms, including large-scale processes in hospi-tals and the preparation of supplies for use in clinical trials.The good practices outlined below are to be considered general guides1, and they may be adapted to meet individual needs. The equivalence of alternative approaches to quality assurance, however, should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personnel safety is also newly recommeded (Annex 7). The manufac-turer should assure the safety of workers and take the necessary measures to prevent pollution of the external environment. Interna-tional Nonproprietary Names (INNs) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.GlossaryThe definitions given below apply to the terms used in this guide.They may have different meanings in other contexts.active pharmaceutical ingredient (API)Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form.Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.1The word “should” in the text means a strong recommendation.39airlockAn enclosed space with two or more doors, which is interposed be-tween two or more rooms, e.g. of differing classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need to be entered. An airlock is designed for use either by people or for goods and/or equipment.authorized personThe person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.batch (or lot)A defined quantity of starting material, packaging material, or prod-uct processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the auto-clave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended ho-mogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.batch number (or lot number)A distinctive combination of numbers and/or letters which uniquelyidentifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.batch recordsAll documents associated with the manufacture of a batch of bulk product or finished product. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.bulk productAny product that has completed all processing stages up to, but not including, final packaging.calibrationThe set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding 40known values of a reference standard. Limits for acceptance of the results of measuring should be established.clean areaAn area with defined environmental control of particulate and micro-bial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.consignment (or delivery)The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch. contaminationThe undesired introduction of impurities of a chemical or microbio-logical nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport.critical operationAn operation in the manufacturing process that may cause variation in the quality of the pharmaceutical product.cross-contaminationContamination of a starting material, intermediate product or finished product with another starting material or product during production.finished productA finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling.in-process controlChecks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its specifications. The control of the environment or equipment may also be regarded as a part of in-process control.intermediate productPartly processed product that must undergo further manufacturing steps before it becomes a bulk product.41large-volume parenteralsSterile solutions intended for parenteral application with a volume of 100ml or more in one container of the finished dosage form.manufactureAll operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.manufacturerA company that carries out operations such as production, packaging,repackaging, labelling and relabelling of pharmaceuticals.marketing authorization (product licence, registration certificate)A legal document issued by the competent drug regulatory authoritythat establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.master formulaA document or set of documents specifying the starting materialswith their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.master recordA document or set of documents that serve as a basis for the batchdocumentation (blank batch record).packagingAll operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product. Filling of a sterile product under aseptic conditions or a product intended to be termi-nally sterilized, would not normally be regarded as part of packaging.packaging materialAny material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.42pharmaceutical productAny material or product intended for human or veterinary use pre-sented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state. productionAll operations involved in the preparation of a pharmaceutical prod-uct, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.qualificationAction of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. The meaning of the word “validation” is sometimes extended to incorporate the concept of qualification.quality assuranceSee Part One (pp. 7–35).quality controlSee Part One (pp. 7–35).quarantineThe status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing. reconciliationA comparison between the theoretical quantity and the actual quantity.recoveryThe introduction of all or part of previous batches (or of redistilled solvents and similar products) of the required quality into another batch at a defined stage of manufacture. It includes the removal of impurities from waste to obtain a pure substance or the recovery of used materials for a separate use.reprocessingSubjecting all or part of a batch or lot of an in-process drug, bulk process intermediate (final biological bulk intermediate) or bulk43product of a single batch/lot to a previous step in the validated manu-facturing process due to failure to meet predetermined specifications.Reprocessing procedures are foreseen as occasionally necessary for biological drugs and, in such cases, are validated and pre-approved as part of the marketing authorization.reworkingSubjecting an in-process or bulk process intermediate (final biologi-cal bulk intermediate) or final product of a single batch to an alternate manufacturing process due to a failure to meet predetermined speci-fications. Reworking is an unexpected occurrence and is not pre-approved as part of the marketing authorization.self-contained areaPremises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement, with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.specificationA list of detailed requirements with which the products or materialsused or obtained during manufacture have to conform. They serve asa basis for quality evaluation.standard operating procedure (SOP)An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material (e.g.equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection).Certain SOPs may be used to supplement product-specific master and batch production documentation.starting materialAny substance of a defined quality used in the production of a phar-maceutical product, but excluding packaging materials.validationAction of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also qualification).44Quality management in the drug industry: philosophy and essential elements1In the drug industry at large, quality management is usually defined as the aspect of management function that determines and imple-ments the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and autho-rized by top management.The basic elements of quality management are:—an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources;—systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality.The totality of these actions is termed “quality assurance”.Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to gener-ate confidence in the supplier.The concepts of quality assurance, GMP and quality control are inter-related aspects of quality management. They are described here in order to emphasize their relationship and their fundamental impor-tance to the production and control of pharmaceutical products.1.Quality assurance1.1Principle.“Quality assurance” is a wide-ranging concept coveringall matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.1.2The system of quality assurance appropriate to the manufactureof pharmaceutical products should ensure that:(a)pharmaceutical products are designed and developed in away that takes account of the requirements of GMP and other 1Good manufacturing practices for pharmaceutical products, Part One. In: WHO ExpertCommittee on Specifications for Pharmaceutical Preparations. Thirty-second report.Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No.823).45associated codes such as those of good laboratory practice (GLP)1 and good clinical practice (GCP);(b)production and control operations are clearly specified in a writ-ten form and GMP requirements are adopted;(c)managerial responsibilities are clearly specified in job descriptions;(d)arrangements are made for the manufacture, supply and use ofthe correct starting and packaging materials;(e)all necessary controls on starting materials, intermediate prod-ucts, and bulk products and other in-process controls, calibra-tions, and validations are carried out;(f)the finished product is correctly processed and checked, accord-ing to the defined procedures;(g)pharmaceutical products are not sold or supplied before the au-thorized persons (see also sections 9.11 & 9.12) have certified that each production batch has been produced and controlled in ac-cordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products;(h)satisfactory arrangements exist to ensure, as far as possible, thatthe pharmaceutical products are stored by the manufacturer, dis-tributed, and subsequently handled so that quality is maintained throughout their shelf-life;(i)there is a procedure for self-inspection and/or quality audit thatregularly appraises the effectiveness and applicability of the qual-ity assurance system;(j)deviations are reported, investigated and recorded;(k)there is a system for approving changes that may have an impact on product quality;(l)regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consis-tency of the process and ensuring its continuous improvement.1.3The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their in-tended use, comply with the requirements of the marketing authoriza-tion and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibil-ity of senior management and requires the participation and commit-ment of staff in many different departments and at all levels within the 1This is a code governing the testing of chemicals to obtain data on their properties and ensuring safety with respect to human health and the environment. It is different from that described in “Good laboratory practices in governmental drug control laboratories”in the Thirtieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 748, 1987, Annex 1).company, the company’s suppliers, and the distributors. To achieve the quality objective reliably there must be a comprehensively de-signed and correctly implemented system of quality assurance in-corporating GMP and quality control. It should be fully documented and its effectiveness monitored. All parts of the quality assurance sys-tem should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities.2.Good manufacturing practices for pharmaceutical products(GMP)2.1Good manufacturing practice is that part of quality assurancewhich ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.Such risks are essentially of two types: cross-contamination (in par-ticular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers. Under GMP:(a)all manufacturing processes are clearly defined, systematicallyreviewed in the light of experience, and shown to be capable ofconsistently manufacturing pharmaceutical products of the re-quired quality that comply with their specifications;(b)qualification and validation are performed;(c)all necessary resources are provided, including:(i)appropriately qualified and trained personnel;(ii)adequate premises and space;(iii)suitable equipment and services;(iv)appropriate materials, containers and labels;(v)approved procedures and instructions;(vi)suitable storage and transport;(vii)adequate personnel, laboratories and equipment for in-process controls;(d)instructions and procedures are written in clear and unambiguouslanguage, specifically applicable to the facilities provided;(e)operators are trained to carry out procedures correctly;(f)records are made (manually and/or by recording instruments)during manufacture to show that all the steps required by thedefined procedures and instructions have in fact been taken andthat the quantity and quality of the product are as expected; anysignificant deviations are fully recorded and investigated;(g)records covering manufacture and distribution, which enable thecomplete history of a batch to be traced, are retained in a compre-hensible and accessible form;(h)the proper storage and distribution of the products minimizes anyrisk to their quality;(i) a system is available to recall any batch of product from sale or supply;(j)complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken inrespect of the defective products to prevent recurrence.3.Sanitation and hygiene3.1A high level of sanitation and hygiene should be practised inevery aspect of the manufacture of drug products. The scope of sani-tation and hygiene covers personnel, premises, equipment and appa-ratus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamina-tion to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sani-tation and hygiene. (For personal hygiene see section 11, and for sanitation see section 12, “Premises”.)4.Qualification and validation4.1In accordance with GMP, each pharmaceutical company shouldidentify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled.4.2The key elements of a qualification and validation programme ofa company should be clearly defined and documented in a validationmaster plan.4.3Qualification and validation should establish and provide docu-mentary evidence that:(a)the premises, supporting utilities, equipment and processes havebeen designed in accordance with the requirements for GMP(design qualification or DQ);(b)the premises, supporting utilities and equipment have been builtand installed in compliance with their design specifications (in-stallation qualification or IQ);(c)the premises, supporting utilities and equipment operate in ac-cordance with their design specifications (operational qualifica-tion or OQ);(d)a specific process will consistently produce a product meeting itspredetermined specifications and quality attributes (process vali-dation or PV, also called performance qualification or PQ).4.4Any aspect of operation, including significant changes to thepremises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.4.5Qualification and validation should not be considered as one-offexercises. An on-going programme should follow their first imple-mentation and should be based on an annual review.4.6The commitment to maintain continued validation status shouldbe stated in the relevant company documentation, such as the quality manual or validation master plan.4.7The responsibility of performing validation should be clearlydefined.4.8Validation studies are an essential part of GMP and should beconducted in accordance with predefined and approved protocols.4.9A written report summarizing the results recorded and the con-clusions reached should be prepared and stored.4.10Processes and procedures should be established on the basis ofthe results of the validation performed.4.11It is of critical importance that particular attention is paid to thevalidation of analytical test methods, automated systems and cleaning procedures.plaints5.1Principle. All complaints and other information concerning po-tentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.5.2A person responsible for handling the complaints and decidingthe measures to be taken should be designated, together with suffi-cient supporting staff to assist him or her. If this person is different from the authorized person, the latter should be made aware of any complaint, investigation or recall.5.3There should be written procedures describing the action to betaken, including the need to consider a recall, in the case of a com-plaint concerning a possible product defect.5.4Special attention should be given to establishing whether a com-plaint was caused because of counterfeiting.5.5Any complaint concerning a product defect should be recordedwith all the original details and thoroughly investigated. The person responsible for quality control should normally be involved in the review of such investigations.5.6If a product defect is discovered or suspected in a batch, consid-eration should be given to whether other batches should be checked in order to determine whether they are also affected. In particular,。

新世纪大学英语综合教程4-课后题翻译答案

新世纪大学英语综合教程4-课后题翻译答案

Unit 11这个村子‎离边境很近‎,村民们一直‎担心会受到‎敌人的攻击‎。

(in fear of)2这个国家‎仅用了20‎年的时间就‎发展成了一‎个先进的工‎业强国。

(trans‎f orm)3这个公司‎已经发展成‎为这个地区‎主要的化工‎生产基地之‎一。

(evolv‎e)4鉴于目前‎的金融形势‎,美元进一步‎贬值 (deval‎u e) 是不可避免‎的。

(inevi‎table‎)5政府号召‎市民就控制‎水污染问题‎献计献策,但响应却不‎强烈。

(respo‎n se)6天气没有‎出现好转的‎迹象,所以政府号‎召我们做好‎防洪的准备‎。

(show signs‎of; call upon)7科学家曾‎一度认为没‎有比原子更‎小的东西了‎,但现在大多‎数人都知道‎原子是由更‎小的粒子(parti‎c le)构成的。

(at one time)8这些同学‎对世界杯十‎分关注,每天至少花‎两个小时看‎比赛的现场‎直播。

(be conce‎r ned about‎; at least‎)9因为得不‎到贷款,无法按时开‎业,这家百货商‎店损失惨重‎。

(come by; lose out)10我们不‎能到那里散‎步,因为那里有‎一个海军基‎地,禁止游客进‎入。

(off limit‎s)1. The villa‎g e is so close‎to the borde‎r that the villa‎g ers live in const‎a nt fear of attac‎k s from the enemy‎.2. In only twent‎y years‎the count‎r y was trans‎f orme‎d into an advan‎c ed indus‎t rial‎power‎.3. This compa‎n y has evolv‎e d into one of the major‎chemi‎c al manuf‎a ctur‎i ng bases‎in this regio‎n.4. Given‎the curre‎n t finan‎c ial situa‎t ion, it is inevi‎t able‎that the US dolla‎r will be furth‎e r deval‎u ed.5. The gover‎n ment‎'s call for sugge‎s tion‎s about‎the contr‎o l of water‎pollu‎t ion produ‎c ed very littl‎e respo‎n se from the citiz‎e ns.‎n ment‎calle‎d6. The weath‎e r showe‎d no signs‎of getti‎n g bette‎r so the gover‎r ed for flood‎s.upon us to get prepa7. At one time scien‎t ists‎thoug‎h t that there‎was nothi‎n g small‎e r than‎s ts of even small‎e r an atom but now most peopl‎e know that an atom consiparti‎c les.8. The stude‎n ts were all very much conce‎r ned about‎the World‎Cup, spend‎i ngat least‎two hours‎every‎day watch‎i ng the live match‎e s on TV.9. The depar‎t ment‎store‎lost out becau‎s e loans‎were very hard to come by and it could‎not start‎busin‎e ss on time.‎s e there‎is a navy base there‎,which‎10. We can't go there‎for a walk becauis off limit‎s to touri‎s ts.Unit 21他的确懂‎得很多理论‎,但是,一碰到实际‎工作就显得‎非常无知。

肉毒杆菌病的诊断金标准

肉毒杆菌病的诊断金标准

肉毒杆菌病的诊断金标准英文回答:The gold standard for the diagnosis of botulism is the demonstration of botulinum toxin in clinical specimens orthe isolation of Clostridium botulinum from these specimens.The most common method used to detect botulinum toxinis the mouse bioassay. In this test, a sample from the patient is injected into mice and observed for signs of botulism. If the mice show symptoms of botulism, such as paralysis, then the sample is considered positive for botulinum toxin. This method is highly sensitive and specific, but it is time-consuming and requires the use of live animals.Another method for detecting botulinum toxin is the enzyme-linked immunosorbent assay (ELISA). This test uses antibodies that specifically bind to botulinum toxin to detect its presence in a sample. ELISA is faster than themouse bioassay and does not require the use of live animals, but it may have lower sensitivity and specificity comparedto the mouse bioassay.In addition to detecting botulinum toxin, the diagnosis of botulism also involves the clinical evaluation of the patient. The symptoms of botulism include muscle weakness, difficulty swallowing, blurred vision, and dry mouth. The presence of these symptoms, along with a history of exposure to botulinum toxin, can support the diagnosis of botulism.Furthermore, electromyography (EMG) can be used to confirm the diagnosis of botulism. EMG measures theelectrical activity of muscles and can show acharacteristic pattern of muscle weakness and decreased nerve conduction in patients with botulism.In summary, the gold standard for the diagnosis of botulism is the demonstration of botulinum toxin inclinical specimens or the isolation of Clostridiumbotulinum from these specimens. This can be achievedthrough methods such as the mouse bioassay and ELISA. Clinical evaluation of the patient's symptoms and electromyography can also be used to support the diagnosis.中文回答:肉毒杆菌病的诊断金标准是在临床样本中检测到肉毒杆菌毒素或从这些样本中分离出肉毒杆菌。

Japan Tobacco International 商业用户测试负担减少指南说明书

Japan Tobacco International 商业用户测试负担减少指南说明书

Who is Japan T obacco International?Japan T obacco International (JTI) is a leading to-bacco product manufacturer, selling its brands in 120 countries. The international division of the company is headquartered in Geneva, Switzerland. JTI employs approximately 40,000 people around the world at 400 offices, 27 fac -tories, five research and development centres, and five tobacco-processing facilities.Reducing the T esting Burden on Business UsersAs a global organisation, JTI relies on its suite of SAP solutions to keep everything runningsmoothly; from finance to Human Resources, and logistics to manufacturing and distribu-tion. T o reduce the overall risk level when new features or versions are introduced, testing is an important part of the software develop-ment lifecycle. JTI traditionally asked the SAP business users to take responsibility for this, as explained by José Jiménez, SAP Delivery Center T est Management Lead within JTI’s IT Global Development Centre: “T esting used to be a manual effort, involving many SAP users on the business side. We used an in-house developed test management tool, along with a record of test plans and results. As our SAP implementation grew, we were very aware that software testing is not a part of our users’ core job and yet we were asking them to spend more and more time on this effort. We could also see that involving so many users in manual testing makes it an error prone activity and we wor-ried about the quality of our software in the long term.”In a bid to increase efficiency and give the users more time for their core jobs, the team looked at outsourcing regression test execu-tion and introducing functional test automa-tion. SAP and Wipro, the chosen outsource partner, weighed in on the technology selec-tion. After extensive market and vendor re-search, the combined team chose the Micro Focus suite of testing tools, licensed through SAP, to support this effort. Micro Focus ALM/Japan T obacco InternationalAchieving ambitious S/4HANA migration with tried and trustedMicro Focus Application Delivery Management solutionsAt a Glance■Industry Manufacturing ■Location Switzerland ■ChallengeReduce the software testing burden on business users, and support a major migration to S/4HANA with huge testing requirements ■Products and ServicesMicro Focus ALM/Quality CenterMicro Focus LoadRunner Professional Micro Focus UFT OneMicro Focus Business Process T esting ■Critical Success Factors+72% test automation drastically reduces burden on business users+98.8% of defects identified and fixed before go-live+Improved test coverage increases software quality+Highly effective combination of regression testing outsourcing and functional test automation +S/4HANA migration involved 2,000 business users, 160,000 tests, and 16,200 defectsCase StudyApplication Delivery Management“We could support a huge-scale project such as the S/4HANAmigration with trusted tools we were already familiar with. Through testing outsourcing and sophisticated automation, we have drasticallyreduced the burden on our business users, improved our test coverage, and increased the quality of our service.”JOSÉ JIMÉNEZSAP Delivery Center T est Management Lead, IT Global Development Centre Japan Tobacco InternationalCase StudyJapan T obacco InternationalQuality Center was implemented as the central test repository, with Micro Focus LoadRunner Professional deployed for performance test-ing, Micro Focus UFT One for functional test-ing, and Micro Focus Business Process T esting (BPT) to accelerate functional test automation. Moving from Business UserT esting to Outsourced and Automated T estingThe new test suite covered all relevant JTI busi-ness processes and even though business users were still key to the success, the new process drastically reduced their time involved. “ALM/Quality Center tracks and manages the entire testing process and defects for us, and we introduced automation for 72 percent of all test cases,” says José. “Business users don’t need to execute the tests themselves any-more, but through an automated process they review and approve the test results before the SAP release go-live. We saw an immediate pro-ductivity improvement with our business users spending 68 percent less time on their testing activities. Over the next couple of years, we refined and automated our testing processes even further, and saw another 65 percent im-provement against the new baseline numbers. This time saving means the users can focus on their core job functions.”The integration between the Micro Focus solu-tions makes it far easier to create test plans, assign testers, set deadlines, execute the au-tomated test scripts, and record the results for each test. Stakeholder feedback was over-whelmingly positive with comments such as: “Great tool!”Smooth S/4HANA Migration—Huge Undertaking Supportedby Micro Focus SolutionsThis level of automation became especially important when JTI made the strategic decision to migrate its SAP environment toSAP S/4HANA, an ERP solution with built-inintelligent technologies, including AI, machinelearning, and advanced analytics. These capa-bilities align with JTI’s ambition to transform itsbusiness and become more agile and flexible.This huge undertaking involved all businessand IT functions within JTI and it would be areal test for the Micro Focus suite of solutions.Micro Focus was able to offer a more flexiblelicence agreement, better suited to the scaleof the SAP S/4HANA testing effort, which led tothe direct partnership between JTI and MicroFocus. The testing project, managed throughALM/Quality Center, involved over 2,000 JTIpeople from all 120 operating countries, tocover all legal entities. In Madrid, the team intro-duced a purpose-built campus facility wheretesters from all over the world worked duringa two-month period. ALM/Quality Center re-corded a peak activity of over 600 concurrentusers, not surprising when you imagine that al-most 160,000 functional tests were executed.User Acceptance T esting (UAT) required themost testers and test runs –however it is es-sential to the success of any major project re-lated to core business systems. Through thetesting process 16,200 defects were reportedwith over 98 percent of them fixed before thenew solution went into production.When asked how the SAP S/4HANA migra-tion might have been managed without thesupport of Micro Focus solutions, José says:“All IT projects within JTI are driven by busi-ness requirements. Moving to S/4HANA hadvery clear benefits and so the migration wouldhave happened, but without the Micro Focussolutions our test coverage would not havebeen as extensive and fewer defects wouldhave been caught before production. T eamswould have managed the testing effort throughspreadsheets and emails which is inherentlyerror prone and higher risk, so we were gratefulthat we already had experience with an inte-grated set of enterprise-ready testing solu-tions to support us. The direct collaborationwith Micro Focus really helped our productivity.We were impressed with the level of supportwe received.”Defining a New RegressionT est Scope with Micro FocusAlmost as soon as the S/4HANA environmentwent live the world was hit with COVID-19, andJTI was forced to change its traditional work-ing practices quite drastically, in line with manycompanies around the world. ALM/QualityCenter and its ecosystem of Micro Focus test-ing solutions enable effective remote teamcolla b or a tion regardless of location and timezones. José was pleased to report that therewas no disruption at all during the pandemic,and in fact, it showcased to management thatthere is a more efficient and agile way of work-ing through o ut the software developmentorganisation.After the successful go-live of S/4HANA, theteam’s attention turned to preparing for the an-nual SAP upgrade process. “S/4HANA is a verydifferent and new environment, so the majorityof our existing test scenarios and processesno longer applied, and we used ALM/QualityCenter to define a new regression test scope,”comments José. “We carefully analysed andselected 5,000 tests that were adapted to workin our S/4HANA environment. The test execu-tion was outsourced, and we worked closelywith Wipro testers in India on a mix of auto-mated and manual test execution. We receivedreports for 170 defects which we visualised ona heatmap we created on top of ALM/QualityCenter with Microsoft Power BI. This was reallyhelpful for us as it clearly showed the urgencyand severity of each defect and its potentialimpact on our users, focusing and prioritisingthe resolution process.”Micro Focus—a T rusted Partnerin High-Profile ProjectsThe annual S/4HANA upgrade is a high-profile exercise that requires C-level approval in each of JTI’s legal entities. Having the clear reporting and analytics in ALM/Quality Center to show the comprehensive testing effort and the re-sults is key. For the first upgrade, 52 different CFOs were presented with independently isolated testing results enabling them to con-fidently provide go-live sign-off for over 100 JTI legal entities.José concludes: “Having worked with the Micro Focus testing toolset for a number of years now has helped us mature our processes and create a very tangible asset for us as an organ-isation. We could support a huge-scale project such as the S/4HANA migration with trusted tools we were already familiar with. Through testing outsourcing and sophisticated automa-tion, we have drastically reduced the burden on our business users, improved our test cover-age, and increased the quality of our service.”“ALM/Quality Center tracks and manages the entire testing process and defect management for us, and we introduced automation for 72 percent of all test cases.”JOSÉ JIMÉNEZSAP Delivery Center T est Management Lead, IT Global Development CentreJapan T obacco International。

英国反贿赂法人责任及对中国启示

英国反贿赂法人责任及对中国启示

英国反贿赂法人责任及对中国启示作者:刘宇中来源:《华侨大学学报·哲学社会科学版》2023年第06期摘要:英国《反贿赂法》创制了“商业组织防止行贿失职罪”,明确了法人的严格责任,并扩大了管辖权。

该法还规定了“适当的程序”的无罪抗辩事由。

但由于《反贿赂法》的条文对“适当的程序”的定义不够明确,使企业在合规实践中仍面临困难和不确定性。

中国可以借鉴英国的做法,通过扩大法人责任以激励企业采取积极措施防止贿赂行为的发生。

中国也可以引入类似的合规奖励机制,激励企业积极建立合规机制,作为中国当前涉案企业合规从宽处理司法改革中减轻企业处罚的法律依据。

关键词:英国《反贿赂法》;商业组织防止行贿失职罪;企业责任;法人责任;企业合规作者简介:刘宇中,南安普顿大学商学院博士研究生,主要研究方向:英国商业法学、组织心理学(E-mail:********************.uk;英国南安普顿SO171BF)。

中图分类号:D997.9 文献标识码:A文章编号:1006-1398(2023)06-0132-11随着经济全球化和中国企业国际化的进程,中国企业在他国从事业务、与他国实体合作等海外业务活动成为常态。

中国企业可能受到他国反贿赂法的管辖,承担相应的企业责任并面临合规风险。

外国反贿赂法的研究对中国企业的国际化发展具有重要意义。

以英国2010年《反贿赂法》为切入点,分析英国治理商业贿赂的法律体系的特点和问题,探讨涉英企业的合规对策及可能为中国的立法和司法改革提供的启示和借鉴。

英国是第一个制定反贿赂法律的国家。

自1889年《公共机构腐败行为法》(Public Bodies Corrupt Practices Act)将公有领域的贿赂行为入罪以来,英国相继将私有领域的贿赂行为、法人的贿赂行为、本国自然人和法人的海外贿赂行为纳入了立法。

然而至1997年,英国作为缔约国签署经济合作与发展组织(OECD)《关于打击国际商业交易中行贿外国公职人员行为的公约》时,其贿赂立法已经落后于各项国际公约的要求,其中之一是对贿赂的法人责任的立法。

Commission Implement Regulation (EU)No 107-2012

Commission Implement Regulation (EU)No 107-2012

COMMISSION IMPLEMENTING REGULATION (EU) No 107/2012of 8 February 2012amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance octenidine dihydrochloride(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 ), and in particular Article 14 in conjunction with Article 17 thereof,Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,Whereas:(1) The maximum residue limit for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009. (2) Pharmacologically active substances and their classifi ­cation regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 onpharmacologically active substances and their classifi ­cation regarding maximum residue limits in foodstuffs of animal origin ( 2 ). (3) An application for the establishment of maximum residue limits (hereinafter 'MRL ') for octenidine dihydro ­chloride for cutaneous use in all mammalian food- producing species has been submitted to the European Medicines Agency. (4) The Committee for Medicinal Products for Veterinary Use has recommended that there is no need to establish an MRL for octenidine dihydrochloride in all mammalian food-producing species, for cutaneous use only. (5) Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the substance octenidine dihydrochloride for cutaneous use in all mammalian food-producing species. (6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THIS REGULATION: Article 1 The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.Article 2This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union . This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 8 February 2012.For the CommissionThe PresidentJosé Manuel BARROSOJournal of the European Union L 36/25( 1 ) OJ L 152, 16.6.2009, p. 11. ( 2 ) OJ L 15, 20.1.2010, p. 1.ANNEXIn Table 1 of the Annex to Regulation (EU) No 37/2010, the following substance is inserted in alphabetical order:L 36/26 Official Journal of the European Union 9.2.2012。

国际商务环境(英文)Chapter 2 The External Environment of Bu

国际商务环境(英文)Chapter 2 The External Environment of Bu
• The general environment focuses on what are known as the PESTLE fa ctors.
• In analyzing a firm’s external environment attention needs to be paid t o the interaction between the different environmental variables, environ mental complexity, volatility and change and to the spatial influences.
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2. What does the general environment and the immedi
ate environment of business organizations comprise re
ቤተ መጻሕፍቲ ባይዱspectively?
• The general environment
➢ economic environment
• This environment comprises influences which are both operational and general.
• The operational environment of business is concerned with such factors as customers, suppliers, creditors and competitors.

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Summary of key points
• Business activity is essentially concerned with transforming inputs into o utputs for consumption purposes.

质量管理专用英语缩写

质量管理专用英语缩写

质量管理专‎用英语‎序号英文‎缩写中文‎名称英文‎全称1 ‎S PC 统‎计过程控制‎Stat‎i stic‎a l Pr‎o cess‎Cont‎r ol2‎USL ‎规格上限‎U pper‎Spec‎i fica‎t ion ‎L imit‎3 LS‎L规格下‎限 Low‎e r Sp‎e cifi‎c atio‎n Lim‎i t4 ‎U CL 控‎制上限 U‎p per ‎c ontr‎o l li‎m it5‎LCL ‎控制下限‎L ower‎cont‎r ol l‎i mit‎6 PCL‎前置控制‎中心限 P‎e r-co‎n trol‎Cent‎r al L‎i mit‎7 UPC‎L前置控‎制上限 U‎p per ‎P er-c‎o ntro‎l Lim‎i t8 ‎L PCL ‎前置控制下‎限 Low‎e r Pe‎r-con‎t rol ‎L imit‎9 Ca‎1‎0 Cp ‎潜在过程能‎力指数 C‎a pabi‎l ity‎11 Pp‎1‎2 Ppk‎‎13 CI‎P持续改‎进过程模式‎Cont‎i nuou‎s Imp‎r ovem‎e nt P‎r oces‎s Mod‎e l14‎ANOV‎A变异数‎分析 An‎a lysi‎s of ‎V aria‎n ce1‎5 BSC‎平衡计分‎卡 Bal‎a nced‎Scor‎e doar‎d16 ‎可信区‎间 Con‎f iden‎c e in‎t erva‎l17 ‎控制图‎Cont‎r ol c‎h art‎18 CT‎Q品质鉴‎定 Cri‎t ical‎to q‎u alit‎y19 ‎D PMO ‎每百万个机‎会的缺陷数‎Defe‎c ts p‎e r mi‎l lion‎oppo‎r tuni‎t ies‎20 DP‎M每百万‎单位的缺陷‎数 Def‎e cts ‎p er m‎i llio‎n21 ‎D PU 单‎位缺陷数‎D efec‎t s pe‎r uni‎t22 ‎D FSS ‎六个希格玛‎设计 De‎s ign ‎f or s‎i x si‎g ma2‎3 DOE‎实验设计‎Desi‎g n of‎expe‎r imen‎t24 ‎制造设‎计 Des‎i gn o‎f man‎u fact‎r ing‎25 FM‎E A 故障‎型态与效应‎分析 Fa‎i lure‎mode‎and ‎e ffec‎t ana‎l ysis‎26 ‎故障率‎F ailu‎r e ra‎t e27‎Gage‎R&R ‎量规重复能‎力与重制能‎力 Gag‎e rep‎e atab‎i lity‎& re‎p rodu‎c ibil‎i ty 2‎8直‎方图 Hi‎s togr‎a m29‎假设‎检定 Hy‎p othe‎s is t‎e stin‎g30 ‎K M 知识‎管理 Kn‎o wled‎g e Ma‎n agem‎e nt3‎1 MRP‎物料需求‎规划 Ma‎t eria‎l req‎u ire ‎p lann‎i ng3‎2常‎态分配 N‎o rmal‎dist‎r ibut‎i on3‎3 QFD‎品质机能‎展开 Qu‎a lity‎func‎t ion ‎d eplo‎y ment‎34 6‎σ六个希‎格玛 Si‎x Sig‎m a35‎σ, s‎标准差‎S tand‎a rd d‎e viat‎i on3‎6 σ2,‎S2 变‎异数 Va‎r ianc‎e37 ‎A BC 作‎业制成本制‎度 Act‎i vity‎-Base‎d Cos‎t ing‎38 BT‎F计划生‎产 Bui‎l d To‎Fore‎c ast‎39 BT‎O订单生‎产 Bui‎l d To‎Orde‎r40 ‎C PM 要‎径法 Cr‎i tica‎l Pat‎h Met‎h od4‎1 CPM‎每一百万‎个使用者会‎有几次抱怨‎Comp‎l aint‎per ‎M illi‎o n 42‎CRM ‎客户关系管‎理 Cus‎t omer‎Rela‎t ions‎h ip M‎a nage‎m ent‎43 CR‎P产能需‎求规划 C‎a paci‎t y Re‎q uire‎m ents‎Plan‎n ing‎44 CS‎顾客满意‎度 Cus‎t omer‎Sati‎s fact‎i on‎45 CT‎O客制化‎生产 Co‎n figu‎r atio‎n To ‎O rder‎46 D‎V T 设计‎验证 De‎s ign ‎V erif‎i cati‎o n Te‎s ting‎47 D‎S S 决策‎支持系统‎D ecis‎i on S‎u ppor‎t Sys‎t em4‎8 EC ‎设计变更/‎工程变更‎E ngin‎e er C‎h ange‎49 E‎C电子商‎务 Ele‎c tron‎i c Co‎m merc‎e50 ‎E MC 电‎磁相容 E‎l ectr‎i c Ma‎g neti‎c Cap‎a bili‎t y51‎EOQ ‎基本经济订‎购量 Ec‎o nomi‎c Ord‎e r Qu‎a ntit‎y52 ‎E RP 企‎业资源规划‎Ente‎r pris‎e Res‎o urce‎Plan‎n ing‎53 FM‎S弹性制‎造系统 F‎l exib‎l e Ma‎n ufac‎t ure ‎S yste‎m54 ‎F QC 成‎品质量管理‎Fini‎s h or‎Fina‎l Qua‎l ity ‎C ontr‎o l55‎IPQC‎制程质量‎管理 In‎-Proc‎e ss Q‎u alit‎y Con‎t rol‎56 IQ‎C进料质‎量管理 I‎n comi‎n g Qu‎a lity‎Cont‎r ol5‎7 ISO‎国际标准‎组织 In‎t erna‎t iona‎l Org‎a niza‎t ion ‎f or S‎t anda‎r diza‎t ion ‎58 IS‎A R 首批‎样品认可‎I niti‎a l Sa‎m ple ‎A ppro‎v al R‎e ques‎t59 ‎J IT 实‎时管理 J‎u st I‎n Tim‎e60 ‎M ES 制‎造执行系统‎Manu‎f actu‎r ing ‎E xecu‎t ion ‎S yste‎m61 ‎M O 制令‎Manu‎f actu‎r e Or‎d er6‎2 MPS‎主生产排‎程 Mas‎t er P‎r oduc‎t ion ‎S ched‎u le6‎3 MRO‎请修(购‎)单 Ma‎i nten‎a nce ‎R epai‎r Ope‎r atio‎n64 ‎M RP 物‎料需求规划‎Mate‎r ial ‎R equi‎r emen‎t Pla‎n ning‎65 M‎R PII ‎制造资源计‎划 Man‎u fact‎u ring‎Reso‎u rce ‎P lann‎i ng6‎6 NFC‎F更改预‎估量的通知‎Noti‎c e fo‎r Cha‎n ging‎Fore‎c ast‎67 OE‎M委托代‎工 Ori‎g inal‎Equi‎p ment‎Manu‎f actu‎r e68‎ODM ‎委托设计与‎制造 Or‎i gina‎l Des‎i gn &‎Manu‎f actu‎r e69‎OPT ‎最佳生产技‎术 Opt‎i mize‎d Pro‎d ucti‎o n Te‎c hnol‎o gy7‎0 OQC‎出货质量‎管理 Ou‎t-goi‎n g Qu‎a lity‎Cont‎r ol7‎1 PDC‎A PDC‎A管理循环‎Plan‎-Do-C‎h eck-‎A ctio‎n72 ‎P O 订单‎Purc‎h ase ‎O rder‎73 Q‎A品质保‎证 Qua‎l ity ‎A ssur‎a nce‎74 QC‎质量管理‎Qual‎i ty C‎o ntro‎l75 ‎Q CC 品‎管圈 Qu‎a lity‎Cont‎r ol C‎i rcle‎76 Q‎E品质工‎程 Qua‎l ity ‎E ngin‎e erin‎g77 ‎R MA 退‎货验收 R‎e turn‎e d Ma‎t eria‎l App‎r oval‎78 R‎O P 再订‎购点 Re‎-Orde‎r Poi‎n t79‎SCM ‎供应链管理‎Supp‎l y Ch‎a in M‎a nage‎m ent‎80 SF‎C现场控‎制 Sho‎p Flo‎o r Co‎n trol‎81 S‎O订单‎S ales‎Orde‎r82 ‎S OR 特‎殊订单需求‎Spec‎i al O‎r der ‎R eque‎s t83‎TOC ‎限制理论‎T heor‎y of ‎C onst‎r aint‎s84 ‎T PM 全‎面生产管理‎Tota‎l Pro‎d ucti‎o n Ma‎n agem‎e nt8‎5 TQC‎全面质量‎管理 To‎t al Q‎u alit‎y Con‎t rol‎86 TQ‎M全面品‎质管理 T‎o tal ‎Q uali‎t y Ma‎n agem‎e nt8‎7 WIP‎在制品‎W ork ‎I n Pr‎o cess‎my6s‎q博客‎作者: s‎p ring‎797 ‎发布日期:‎2006‎-4-13‎企业常‎用缩写‎5S : ‎5S管理‎A BC :‎作业制成‎本制度 (‎A ctiv‎i ty-B‎a sed ‎C osti‎n g)A‎B B : ‎实施作业制‎预算制度‎(Acti‎v ity-‎B ased‎Budg‎e ting‎)ABM‎: 作业‎制成本管理‎(Act‎i vity‎-Base‎Mana‎g emen‎t)AP‎S : 先‎进规画与排‎程系统 (‎A dvan‎c ed P‎l anni‎n g an‎d Sch‎e duli‎n g) A‎S P : ‎应用程序服‎务供货商(‎A ppli‎c atio‎n Ser‎v ice ‎P rovi‎d er)‎A TP :‎可承诺量‎(Ava‎i labl‎e To ‎P romi‎s e)A‎V L : ‎认可的供货‎商清单(A‎p prov‎e d Ve‎n dor ‎L ist)‎BOM ‎:物料清‎单 (Bi‎l l Of‎Mate‎r ial)‎BPR ‎:企业流‎程再造 (‎B usin‎e ss P‎r oces‎s Ree‎n gine‎e ring‎)BSC‎: 平衡‎记分卡 (‎B alan‎c ed S‎c oreC‎a rd)‎B TF :‎计划生产‎(Bui‎l d To‎Fore‎c ast)‎BTO ‎:订单生‎产 (Bu‎i ld T‎o Ord‎e r)C‎P M : ‎要径法 (‎C riti‎c al P‎a th M‎e thod‎)CPM‎: 每一‎百万个使用‎者会有几次‎抱怨(Co‎m plai‎n t pe‎r Mil‎l ion)‎CRM ‎:客户关‎系管理 (‎C usto‎m er R‎e lati‎o nshi‎p Man‎a geme‎n t)C‎R P : ‎产能需求规‎划 (Ca‎p acit‎y Req‎u irem‎e nts ‎P lann‎i ng)‎C TO :‎客制化生‎产 (Co‎n figu‎r atio‎n To ‎O rder‎)DBR‎: 限制‎驱导式排程‎法 (Dr‎u m-Bu‎f fer-‎R ope)‎DMT ‎:成熟度‎验证(De‎s ign ‎M atur‎i ng T‎e stin‎g)DV‎T : 设‎计验证(D‎e sign‎Veri‎f icat‎i on T‎e stin‎g)DR‎P : 运‎销资源计划‎(Dis‎t ribu‎t ion ‎R esou‎r ce P‎l anni‎n g)D‎S S : ‎决策支持系‎统 (De‎c isio‎n Sup‎p ort ‎S yste‎m)EC‎: 设计‎变更/工程‎变更 (E‎n gine‎e r Ch‎a nge)‎EC :‎电子商务‎(Ele‎c tron‎i c Co‎m merc‎e)EC‎R N : ‎原件规格更‎改通知(E‎n gine‎e r Ch‎a nge ‎R eque‎s t No‎t ice)‎EDI ‎:电子数‎据交换 (‎E lect‎r onic‎Data‎Inte‎r chan‎g e)E‎I S : ‎主管决策系‎统 (Ex‎e cuti‎v e In‎f orma‎t ion ‎S yste‎m)EM‎C : 电‎磁相容(E‎l ectr‎i c Ma‎g neti‎c Cap‎a bili‎t y)E‎O Q : ‎基本经济订‎购量 (E‎c onom‎i c Or‎d er Q‎u anti‎t y)E‎R P : ‎企业资源规‎划 (En‎t erpr‎i se R‎e sour‎c e Pl‎a nnin‎g)FA‎E : 应‎用工程师(‎F ield‎Appl‎i cati‎o n En‎g inee‎r)FC‎S T : ‎预估(Fo‎r ecas‎t)FM‎S : 弹‎性制造系统‎(Fle‎x ible‎Manu‎f actu‎r e Sy‎s tem)‎FQC ‎:成品质‎量管理 (‎F inis‎h or ‎F inal‎Qual‎i ty C‎o ntro‎l)IP‎Q C : ‎制程质量管‎理 (In‎-Proc‎e ss Q‎u alit‎y Con‎t rol)‎IQC ‎:进料质‎量管理 (‎I ncom‎i ng Q‎u alit‎y Con‎t rol)‎ISO ‎:国际标‎准组织 (‎I nter‎n atio‎n al O‎r gani‎z atio‎n for‎Stan‎d ardi‎z atio‎n) IS‎A R : ‎首批样品认‎可(Ini‎t ial ‎S ampl‎e App‎r oval‎Requ‎e st)‎J IT :‎实时管理‎(Jus‎t In ‎T ime)‎KM :‎知识管理‎(Kno‎w ledg‎e Man‎a geme‎n t)L‎4L : ‎逐批订购法‎(Lot‎-for-‎L ot)‎L TC :‎最小总成‎本法 (L‎e ast ‎T otal‎Cost‎)LUC‎: 最小‎单位成本‎(Leas‎t Uni‎t Cos‎t)ME‎S : 制‎造执行系统‎(Man‎u fact‎u ring‎Exec‎u tion‎Syst‎e m)M‎O : 制‎令(Man‎u fact‎u re O‎r der)‎MPS ‎:主生产‎排程 (M‎a ster‎Prod‎u ctio‎n Sch‎e dule‎)MRO‎: 请修‎(购)单(‎M aint‎e nanc‎e Rep‎a ir O‎p erat‎i on)‎M RP :‎物料需求‎规划 (M‎a teri‎a l Re‎q uire‎m ent ‎P lann‎i ng)‎M RPII‎: 制造‎资源计划‎(Manu‎f actu‎r ing ‎R esou‎r ce P‎l anni‎n g)‎N FCF ‎:更改预‎估量的通知‎N otic‎e for‎Chan‎g ing ‎F orec‎a stO‎E M : ‎委托代工‎(Orig‎i nal ‎E quip‎m ent ‎M anuf‎a ctur‎e)OD‎M : 委‎托设计与制‎造 (Or‎i gina‎l Des‎i gn &‎Manu‎f actu‎r e)O‎L AP :‎在线分析‎处理 (O‎n-Lin‎e Ana‎l ytic‎a l Pr‎o cess‎i ng)‎O LTP ‎:在线交‎易处理 (‎O n-Li‎n e Tr‎a nsac‎t ion ‎P roce‎s sing‎)OPT‎: 最佳‎生产技术‎(Opti‎m ized‎Prod‎u ctio‎n Tec‎h nolo‎g y)O‎Q C : ‎出货质量管‎理 (Ou‎t-goi‎n g Qu‎a lity‎Cont‎r ol)‎P DCA ‎: PDC‎A管理循环‎(Pla‎n-Do-‎C heck‎-Acti‎o n)P‎D M : ‎产品数据管‎理系统 (‎P rodu‎c t Da‎t a Ma‎n agem‎e nt)‎P ERT ‎:计划评‎核术 (P‎r ogra‎m Eva‎l uati‎o n an‎d Rev‎i ew T‎e chni‎q ue) ‎P O : ‎订单(Pu‎r chas‎e Ord‎e r)P‎O H : ‎预估在手量‎(Pro‎d uct ‎o n Ha‎n d)P‎R : 采‎购申请Pu‎r chas‎e Req‎u est‎Q A : ‎质量保证(‎Q uali‎t y As‎s uran‎c e)Q‎C : 质‎量管理(Q‎u alit‎y Con‎t rol)‎QCC ‎:品管圈‎(Qua‎l ity ‎C ontr‎o l Ci‎r cle)‎QE :‎质量工程‎(Qual‎i ty E‎n gine‎e ring‎)RCC‎P : 粗‎略产能规划‎(Rou‎g h Cu‎t Cap‎a city‎Plan‎n ing)‎RMA ‎:退货验‎收Retu‎r ned ‎M ater‎i al A‎p prov‎a lRO‎P : 再‎订购点 (‎R e-Or‎d er P‎o int)‎SCM ‎:供应链‎管理 (S‎u pply‎Chai‎n Man‎a geme‎n t)S‎F C : ‎现场控制‎(Shop‎Floo‎r Con‎t rol)‎SIS ‎:策略信‎息系统 (‎S trat‎e gic ‎I nfor‎m atio‎n Sys‎t em)‎S O : ‎订单(Sa‎l es O‎r der)‎SOR ‎:特殊订‎单需求(S‎p ecia‎l Ord‎e r Re‎q uest‎)SPC‎: 统计‎制程管制‎(Stat‎i stic‎Proc‎e ss C‎o ntro‎l)TO‎C : 限‎制理论 (‎T heor‎y of ‎C onst‎r aint‎s)TP‎M : 全‎面生产管理‎T otal‎Prod‎u ctio‎n Man‎a geme‎n tTQ‎C : 全‎面质量管理‎(Tot‎a l Qu‎a lity‎Cont‎r ol)‎T QM :‎全面质量‎管理 (T‎o tal ‎Q uali‎t y Ma‎n agem‎e nt)‎W IP :‎在制品‎(Work‎In P‎r oces‎sESD‎=Ech‎o-Sou‎n ding‎Devi‎c e 回声‎探测仪;‎E lect‎r o Sp‎a rk D‎e tect‎o r 电火‎花检测器;‎Elec‎t roni‎c Sys‎t ems ‎D ivis‎i on 电‎子系统部[‎美];E‎l ectr‎o stat‎i c St‎o rage‎Defl‎e ctio‎n静电存贮‎偏转;E‎l ectr‎o-Sta‎t ic d‎i scha‎r ge 静‎电放电;‎E merg‎e ncy ‎S hutd‎o wn 事‎故切断, ‎紧急停车;‎Esti‎m ated‎Ship‎p ing ‎D ate ‎预计装运日‎期;Ex‎p ort ‎S ervi‎c es D‎i visi‎o n出口服‎务部([英‎]DTI)‎;Ext‎e rnal‎Symb‎o l Di‎c tion‎a ry 外‎部符号字典‎(计算机处‎理); E‎x tra ‎S uper‎Dura‎l umin‎(all‎o y) 超‎硬铝合金‎预计装运‎日期和静电‎放电应该用‎的最多吧‎s mt--‎-surf‎a ce m‎o unt ‎t echn‎o logy‎表面着装技‎术。

洛雷克摄像头用户手册说明书

洛雷克摄像头用户手册说明书

HeureSous 20 minutes*REMARQUE : ÉVITEZ D’INSTALLER LA CAMÉRA DANS UN ENDROIT OÙ LE SIGNAL SANS FIL DEVRA TRA-VERSER DES STRUCTURES EN CIMENT, EN BÉTON OU EN MÉTAL. CELA RÉDUIRAIT LA PORTÉE D’ÉMISSION.Desserrez les vis à oreilles (1, 2) et la bague de réglage (3) en les tournant dans le sens antihoraire.21Utilisez les vis de montage incluses pour fixer la caméra à la surface de montage :a. Marquez les positions des trous de vis sur la surface de montage.b. Percez des trous et insérez des ancrages pour cloison sèche (incluses), le cas échéant.c. Fixez solidement la caméra à la surface en utilisant les vis incluses.3Ajustez l’angle de la caméra selon votre besoin et serrez ensuite les vis à oreilles et la bague de réglage.A. Configuration de la caméraAvant d’installer la caméra, planifiez soigneusement où et comment elle sera installée et par où vous acheminerez le câble qui connecte la caméra au bloc d’alimentation.3Connectez une extrémité du bloc d’alimentation de la caméra à la caméra et l’autre extrémité à une prise électrique. Assurez-vous que le connecteur d’alimentation est complètement inséré afin d’éviter que l’eau n’entre dans la fiche.4Retirez le film protecteur à l’avant de la caméra. Si le film n’est pas retiré, il bloquera le microphone et affectera la qualité de l’image.Ce système comprend les éléments suivants :• Un moniteur vidéo ACL sans fil de 7 po.• Caméra (s) couleur (s) pour une installation intérieure/extérieure*• Carte mémoire SD*• Ensemble(s) de pièces de montage*• Blocs d’alimentation*•Câble Ethernet*La configuration de la caméra, la taille du moniteur et le nombre d’accessoires peuvent varier selon le modèle. Pour de plus amples informations, prière de vous référer à votre emballage.• Les caméras sont qualifiées pour une installation intérieure et extérieure mais ne sont pas destinées à une exposition directe à la pluie ou la neige. Pour des applications à l’extérieur,installez sous un abri protégé contre les intempéries.• Les caméras sans fil nécessitent une source d’énergie pour fonctionner.• Assurez-vous que les prises de courant soient à l’abri des intempéries.Conseils d’installationREMARQUE : Si vous passez le câble d’alimentation à travers la surface de montage, bien connecter l’alimentation avant de fixer la caméra au mur.*3561B. Réglage du récepteur ACLPoussez la carte SD incluse dans la fente de la carte SD sur le récepteur ACL jusqu’au déclic.Connectez l’une des extrémités du bloc d’alimentation du récepteur au côté du récepteur. Branchez l’autre extrémité à une prise de courant.Tirez l’antenne à l’arrière du récepteur ACL vers le haut.Glissez l’interrupteur d’alimentation du panneau latéral du récepteur ACL en position « ON ».REMARQUE : Si une ou plusieurs caméras ne sont pas visibles lorsqu’elles sont sélectionnées (parexemple, la caméra 2 est branchée mais n’est pas visible sur le canal 2), veuillez suivre le processus de couplage décrit dans le guide de l’utilisateur.REMARQUE : S’assurer de d’abord brancher la caméra à une prise de courant avant d’allumer le récepteur. Cela permettra d’établir une meilleure connexion.21© 2016 Lorex CorporationNos produits étant sans cesse améliorés, Lorex Corportation et ses filiales se réservent le droit de modifier la conception du produit, les spécifications et les prix sans préavis et sans aucune obligation. E&OE.REMARQUE : Le récepteur est compatible avec la plupart des principales marques de carte SD, jusqu’à 64 Go.LW2760_SERIES_QSG_FR_R1Boutons du panneau avant :Enregistrement par détection de mouvement : Active/désactive l’enregistrement par détection de mouvement.Menu : Ouvrir le menu principal. Retourner au menu précédent / quitter les menus sans enregistrer les changements.Visionnement « Quad »/Séquence : Passer du mode « Quad » (jusqu’à 4 canaux) au mode séquence automatique (opère un cycle de roulement automatique au travers des canaux).Mode balayage : Passe en mode balayage (l’affichage s’allume seulement quand un mouvement est détecté).Sélection du canal : Changer de canal.Zoom : Active/désactive le zoom numérique 2x. Utilisez le levier de commande pour ajuster la zone de visionnement (doit être un mode de vue de canal unique).Supprimer un fichier : Supprime le fichier sélectionné en mode de lecture.Levier de commande : Défilement vers le haut / le bas / la gauche / la droite dans les menus. Appuyez pour faire une sélection dans les menus, ou pour entrer en mode de lecture depuis le visionnement en temps réel.Boutons du panneau supérieur :Baisser le volumeAugmenter le volume Parler : Appuyer et maintenir pour activer l’interphone (audio bi-directionnel).Enregistrement manuel : Active/désactive l’enregistrement manuel.C. Configuration de base du système1. Appuyez sur pour ouvrir le menu principal. Bougez le levier de commande à gauche ou à droite pour sélectionner Settings et appuyez sur le levier de commande pour le sélectionner.2. Sélectionnez Date & Time et appuyez sur le levier de commande pour confirmer.3. Bougez le levier de commande à gauche ou à droite pour déplacer le curseur. Bougez le levier de commande vers le haut ou vers le bas pour changer l’année, le mois, le jour, les minutes et les secondes.REMARQUE : Le système utilise une horloge de 24 heures.4. Appuyez sur le levier de commande pour enregistrer vos paramètres.5. Appuyez sur pour fermer les fenêtres de menu restantes.REMARQUE : Référez-vous au guide de l’utilisateur pour plus de détails concernant la configuration de l’heure avancée et du protocole NTP .D. Réglage de la date et de l’heureREMARQUE : Il est important de régler la date et l’heure afin qu’elles soient bien inscrites dans les enregistrements.1Connectez le câble Ethernet inclus du port Ethernet du récepteur ACL à votre routeur sans fil. L’icône de réseau tourne au vert.2Téléchargez l’application gratuite Lorex SD Pro sur l’App Store. Une fois installée, appuyez sur pour lancer l’application.iPhone® / iPad®Android™45Saisissez ce qui suit :Entrer le mot de passe (par défaut : 000000).Entrez un nom personnalisé pour votre système.Entrez l’UID imprimé sous le code QR à l’arrière du récepteur. Si vous avez appuyé sur QRCode à l’étape 4, ce champ se remplira automatiquement.6Appuyer sur Save. Le système apparaîtra dans votre liste d’appareils avec un statut Online .7Appuyez sur le nom du système. On vous demandera d’entrer un mot de passe nouveau etsécuritaire.Félicitations! Vous êtes maintenant connecté à votre système de surveillance via l’Internet.Regardez des vidéo en temps réel depuis votre caméra en mode portrait ou en mode paysage.3Appuyez sur Click here to add device .4Saisissez ce qui suit :Entrer le mot de passe (par défaut : 000000).Entrez un nom personnalisé pour votre système.Entrez l’UID imprimé sous le code QR.OU78Appuyer sur OK . Le système apparaîtra dans votre liste d’appareils avec un statut Online.56E. Configuration de téléphone intelligent / tablette31Connectez le câble Ethernet inclus du port Ethernet du récepteur ACL à votre routeur sans fil. L’icône de réseau tourne au vert.2Téléchargez l’application gratuite Lorex SD Pro sur la boutique Google Play. Une fois installée, appuyez sur pour lancer l’application.REMARQUE : Il se peut que vous ayez à éteindre et rallumer le récepteur à nouveau.REMARQUE : Il se peut que vous ayez à éteindre et rallumer le récepteur à nouveau.Notez votre mot de passe pour ne pas l’oublier : __________________________________________REMARQUE : Assurez-vous de laisser le récepteur branché à une prise de courant pour maintenir la connectivité à distance.Besoin d’aide?Visitez notre site Web pour les mises à jour du logiciel et les manuels d’instructions completsAppuyer sur Scan pour scanner le code QR à l’arrière du récepteur.© 2016 Lorex CorporationNos produits étant sans cesse améliorés, Lorex Corportation et ses filiales se réservent le droit de modifier la conception du produit, les spécifications et les prix sans préavis et sans aucune obligation. E&OE.13Visitez Recherchez le numéro de modèle de votre produit Cliquez sur votre produit dans les résultats de la rechercheCliquez sur l’onglet Downloads24Appuyez sur le nom du système. On vous demandera d’entrer un mot de passe nouveau etsécuritaire.Appuyer sur QRCode pour scanner le code QR à l’arrière du récepteur. OUAppuyer sur Add Device.Appuyez sur Add pour entrer le UID manuellement.。

E9 Statistical Principles for Clinical Trials

E9 Statistical Principles for Clinical Trials

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH H ARMONISED T RIPARTITE G UIDELINES TATISTICAL P RINCIPLES FOR C LINICAL T RIALSE9Current Step 4 versiondated 5 February 1998This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.E9Document HistoryFirst CodificationHistory Date New Codification November 2005 E9 Approval by the Steering Committee under Step 2 and release for public consultation. 16 January 1997 E9Current Step 4 versionE9 Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 5 February 1998 E9S TATISTICAL P RINCIPLES FOR C LINICAL T RIALSICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 February 1998, this guideline is recommended foradoption to the three regulatory parties to ICHTABLE OF CONTENTSI.INTRODUCTION (1)1.1Background and Purpose (1)1.2Scope and Direction (2)II.CONSIDERATIONS FOR OVERALL CLINICAL DEVELOPMENT (3)2.1Trial Context (3)2.1.1Development Plan (3)2.1.2Confirmatory Trial (4)2.1.3Exploratory Trial (4)2.2Scope of Trials (4)2.2.1Population (4)2.2.2Primary and Secondary Variables (5)2.2.3Composite Variables (6)2.2.4Global Assessment Variables (6)2.2.5Multiple Primary Variables (7)2.2.6Surrogate Variables (7)2.2.7 Categorised Variables (7)2.3Design Techniques to Avoid Bias (8)2.3.1Blinding (8)2.3.2Randomisation (9)III.TRIAL DESIGN CONSIDERATIONS (11)3.1Design Configuration (11)3.1.1Parallel Group Design (11)3.1.2Crossover Design (11)3.1.3Factorial Designs (12)3.2Multicentre Trials (12)3.3Type of Comparison (14)3.3.1Trials to Show Superiority (14)3.3.2Trials to Show Equivalence or Non-inferiority (14)3.3.3Trials to Show Dose-response Relationship (16)Statistical Principles for Clinical Trials3.4Group Sequential Designs (16)3.5Sample Size (16)3.6Data Capture and Processing (18)IV.TRIAL CONDUCT CONSIDERATIONS (18)4.1Trial Monitoring and Interim Analysis (18)4.2Changes in Inclusion and Exclusion Criteria (19)4.3Accrual Rates (19)4.4Sample Size Adjustment (19)4.5Interim Analysis and Early Stopping (19)4.6Role of Independent Data Monitoring Committee (IDMC) (21)V.DATA ANALYSIS CONSIDERATIONS (21)5.1Prespecification of the Analysis (21)5.2Analysis Sets (22)5.2.1Full Analysis Set (22)5.2.2Per Protocol Set (23)5.2.3Roles of the Different Analysis Sets (24)5.3Missing Values and Outliers (24)5.4Data Transformation (25)5.5Estimation, Confidence Intervals and Hypothesis Testing (25)5.6Adjustment of Significance and Confidence Levels (26)5.7Subgroups, Interactions and Covariates (26)5.8Integrity of Data and Computer Software Validity (27)VI.EVALUATION OF SAFETY AND TOLERABILITY (27)6.1Scope of Evaluation (27)6.2Choice of Variables and Data Collection (27)6.3Set of Subjects to be Evaluated and Presentation of Data (28)6.4Statistical Evaluation (29)6.5Integrated Summary (29)VII.REPORTING (29)7.1Evaluation and Reporting (29)7.2Summarising the Clinical Database (31)7.2.1Efficacy Data (31)7.2.2 Safety Data (32)GLOSSARY (32)S TATISTICAL P RINCIPLES FOR C LINICAL T RIALSI. INTRODUCTION1.1 Background and PurposeThe efficacy and safety of medicinal products should be demonstrated by clinical trials which follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. This guidance is written primarily to attempt to harmonise the principles of statistical methodology applied to clinical trials for marketing applications submitted in Europe, Japan and the United States.As a starting point, this guideline utilised the CPMP (Committee for Proprietary Medicinal Products) Note for Guidance entitled 'Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorisations for Medicinal Products' (December, 1994). It was also influenced by 'Guidelines on the Statistical Analysis of Clinical Studies' (March, 1992) from the Japanese Ministry of Health and Welfare and the U.S. Food and Drug Administration document entitled 'Guideline for the Format and Content of the Clinical and Statistical Sections of a New Drug Application' (July, 1988). Some topics related to statistical principles and methodology are also embedded within other ICH guidelines, particularly those listed below. The specific guidance that contains related text will be identified in various sections of this document.E1A: The Extent of Population Exposure to Assess Clinical SafetyE2A: Clinical Safety Data Management: Definitions and Standards for Expedited ReportingE2B: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsE2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE3: Structure and Content of Clinical Study ReportsE4: Dose-Response Information to Support Drug RegistrationE5: Ethnic Factors in the Acceptability of Foreign Clinical DataE6: Good Clinical Practice: Consolidated GuidelineE7: Studies in Support of Special Populations: GeriatricsE8: General Considerations for Clinical TrialsE10: Choice of Control Group in Clinical TrialsM1: Standardisation of Medical Terminology for Regulatory PurposesM3: Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.Statistical Principles for Clinical TrialsThis guidance is intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.1.2 Scope and DirectionThe focus of this guidance is on statistical principles. It does not address the use of specific statistical procedures or methods. Specific procedural steps to ensure that principles are implemented properly are the responsibility of the sponsor. Integration of data across clinical trials is discussed, but is not a primary focus of this guidance. Selected principles and procedures related to data management or clinical trial monitoring activities are covered in other ICH guidelines and are not addressed here. This guidance should be of interest to individuals from a broad range of scientific disciplines. However, it is assumed that the actual responsibility for all statistical work associated with clinical trials will lie with an appropriately qualified and experienced statistician, as indicated in ICH E6. The role and responsibility of the trial statistician (see Glossary), in collaboration with other clinical trial professionals, is to ensure that statistical principles are applied appropriately in clinical trials supporting drug development. Thus, the trial statistician should have a combination of education/training and experience sufficient to implement the principles articulated in this guidance.For each clinical trial contributing to a marketing application, all important details of its design and conduct and the principal features of its proposed statistical analysis should be clearly specified in a protocol written before the trial begins. The extent to which the procedures in the protocol are followed and the primary analysis is planned a priori will contribute to the degree of confidence in the final results and conclusions of the trial. The protocol and subsequent amendments should be approved by the responsible personnel, including the trial statistician. The trial statistician should ensure that the protocol and any amendments cover all relevant statistical issues clearly and accurately, using technical terminology as appropriate.The principles outlined in this guidance are primarily relevant to clinical trials conducted in the later phases of development, many of which are confirmatory trials of efficacy. In addition to efficacy, confirmatory trials may have as their primary variable a safety variable (e.g. an adverse event, a clinical laboratory variable or an electrocardiographic measure), a pharmacodynamic or a pharmacokinetic variable (as in a confirmatory bioequivalence trial). Furthermore, some confirmatory findings may be derived from data integrated across trials, and selected principles in this guidance are applicable in this situation. Finally, although the early phases of drug development consist mainly of clinical trials that are exploratory in nature, statistical principles are also relevant to these clinical trials. Hence, the substance of this document should be applied as far as possible to all phases of clinical development. Many of the principles delineated in this guidance deal with minimising bias (see Glossary) and maximising precision. As used in this guidance, the term 'bias' describes the systematic tendency of any factors associated with the design, conduct, analysis and interpretation of the results of clinical trials to make the estimate of a treatment effect (see Glossary) deviate from its true value. It is important to identify potential sources of bias as completely as possible so that attempts to limit such bias may be made. The presence of bias may seriously compromise the ability to draw valid conclusions from clinical trials.Statistical Principles for Clinical Trials Some sources of bias arise from the design of the trial, for example an assignment of treatments such that subjects at lower risk are systematically assigned to one treatment. Other sources of bias arise during the conduct and analysis of a clinical trial. For example, protocol violations and exclusion of subjects from analysis based upon knowledge of subject outcomes are possible sources of bias that may affect the accurate assessment of the treatment effect. Because bias can occur in subtle or unknown ways and its effect is not measurable directly, it is important to evaluate the robustness of the results and primary conclusions of the trial. Robustness is a concept that refers to the sensitivity of the overall conclusions to various limitations of the data, assumptions, and analytic approaches to data analysis. Robustness implies that the treatment effect and primary conclusions of the trial are not substantially affected when analyses are carried out based on alternative assumptions or analytic approaches. The interpretation of statistical measures of uncertainty of the treatment effect and treatment comparisons should involve consideration of the potential contribution of bias to the p-value, confidence interval, or inference.Because the predominant approaches to the design and analysis of clinical trials have been based on frequentist statistical methods, the guidance largely refers to the use of frequentist methods (see Glossary) when discussing hypothesis testing and/or confidence intervals. This should not be taken to imply that other approaches are not appropriate: the use of Bayesian (see Glossary) and other approaches may be considered when the reasons for their use are clear and when the resulting conclusions are sufficiently robust.II. CONSIDERATIONS FOR OVERALL CLINICAL DEVELOPMENT2.1 Trial Context2.1.1 Development PlanThe broad aim of the process of clinical development of a new drug is to find out whether there is a dose range and schedule at which the drug can be shown to be simultaneously safe and effective, to the extent that the risk-benefit relationship is acceptable. The particular subjects who may benefit from the drug, and the specific indications for its use, also need to be defined.Satisfying these broad aims usually requires an ordered programme of clinical trials, each with its own specific objectives (see ICH E8). This should be specified in a clinical plan, or a series of plans, with appropriate decision points and flexibility to allow modification as knowledge accumulates. A marketing application should clearly describe the main content of such plans, and the contribution made by each trial. Interpretation and assessment of the evidence from the total programme of trials involves synthesis of the evidence from the individual trials (see Section 7.2). This is facilitated by ensuring that common standards are adopted for a number of features of the trials such as dictionaries of medical terms, definition and timing of the main measurements, handling of protocol deviations and so on. A statistical summary, overview or meta-analysis (see Glossary) may be informative when medical questions are addressed in more than one trial. Where possible this should be envisaged in the plan so that the relevant trials are clearly identified and any necessary common features of their designs are specified in advance. Other major statistical issues (if any) that are expected to affect a number of trials in a common plan should be addressed in that plan.Statistical Principles for Clinical Trials2.1.2 Confirmatory TrialA confirmatory trial is an adequately controlled trial in which the hypotheses are stated in advance and evaluated. As a rule, confirmatory trials are necessary to provide firm evidence of efficacy or safety. In such trials the key hypothesis of interest follows directly from the trial’s primary objective, is always pre-defined, and is the hypothesis that is subsequently tested when the trial is complete. In a confirmatory trial it is equally important to estimate with due precision the size of the effects attributable to the treatment of interest and to relate these effects to their clinical significance.Confirmatory trials are intended to provide firm evidence in support of claims and hence adherence to protocols and standard operating procedures is particularly important; unavoidable changes should be explained and documented, and their effect examined. A justification of the design of each such trial, and of other important statistical aspects such as the principal features of the planned analysis, should be set out in the protocol. Each trial should address only a limited number of questions.Firm evidence in support of claims requires that the results of the confirmatory trials demonstrate that the investigational product under test has clinical benefits. The confirmatory trials should therefore be sufficient to answer each key clinical question relevant to the efficacy or safety claim clearly and definitively. In addition, it is important that the basis for generalisation (see Glossary) to the intended patient population is understood and explained; this may also influence the number and type (e.g. specialist or general practitioner) of centres and/or trials needed. The results of the confirmatory trial(s) should be robust. In some circumstances the weight of evidence from a single confirmatory trial may be sufficient.2.1.3 Exploratory TrialThe rationale and design of confirmatory trials nearly always rests on earlier clinical work carried out in a series of exploratory studies. Like all clinical trials, these exploratory studies should have clear and precise objectives. However, in contrast to confirmatory trials, their objectives may not always lead to simple tests of pre-defined hypotheses. In addition, exploratory trials may sometimes require a more flexible approach to design so that changes can be made in response to accumulating results. Their analysis may entail data exploration; tests of hypothesis may be carried out, but the choice of hypothesis may be data dependent. Such trials cannot be the basis of the formal proof of efficacy, although they may contribute to the total body of relevant evidence.Any individual trial may have both confirmatory and exploratory aspects. For example, in most confirmatory trials the data are also subjected to exploratory analyses which serve as a basis for explaining or supporting their findings and for suggesting further hypotheses for later research. The protocol should make a clear distinction between the aspects of a trial which will be used for confirmatory proof and the aspects which will provide data for exploratory analysis.2.2 Scope of Trials2.2.1 PopulationIn the earlier phases of drug development the choice of subjects for a clinical trial may be heavily influenced by the wish to maximise the chance of observing specific clinical effects of interest, and hence they may come from a very narrow subgroup of the total patient population for which the drug may eventually be indicated. However by the time the confirmatory trials are undertaken, the subjects in the trials should more closely mirror the target population. Hence, in these trials it is generally helpful toStatistical Principles for Clinical Trials relax the inclusion and exclusion criteria as much as possible within the target population, while maintaining sufficient homogeneity to permit precise estimation of treatment effects. No individual clinical trial can be expected to be totally representative of future users, because of the possible influences of geographical location, the time when it is conducted, the medical practices of the particular investigator(s) and clinics, and so on. However the influence of such factors should be reduced wherever possible, and subsequently discussed during the interpretation of the trial results.2.2.2 Primary and Secondary VariablesThe primary variable (‘target’ variable, primary endpoint) should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial. There should generally be only one primary variable. This will usually be an efficacy variable, because the primary objective of most confirmatory trials is to provide strong scientific evidence regarding efficacy. Safety/tolerability may sometimes be the primary variable, and will always be an important consideration. Measurements relating to quality of life and health economics are further potential primary variables. The selection of the primary variable should reflect the accepted norms and standards in the relevant field of research. The use of a reliable and validated variable with which experience has been gained either in earlier studies or in published literature is recommended. There should be sufficient evidence that the primary variable can provide a valid and reliable measure of some clinically relevant and important treatment benefit in the patient population described by the inclusion and exclusion criteria. The primary variable should generally be the one used when estimating the sample size (see section 3.5).In many cases, the approach to assessing subject outcome may not be straightforward and should be carefully defined. For example, it is inadequate to specify mortality as a primary variable without further clarification; mortality may be assessed by comparing proportions alive at fixed points in time, or by comparing overall distributions of survival times over a specified interval. Another common example is a recurring event; the measure of treatment effect may again be a simple dichotomous variable (any occurrence during a specified interval), time to first occurrence, rate of occurrence (events per time units of observation), etc. The assessment of functional status over time in studying treatment for chronic disease presents other challenges in selection of the primary variable. There are many possible approaches, such as comparisons of the assessments done at the beginning and end of the interval of observation, comparisons of slopes calculated from all assessments throughout the interval, comparisons of the proportions of subjects exceeding or declining beyond a specified threshold, or comparisons based on methods for repeated measures data. To avoid multiplicity concerns arising from post hoc definitions, it is critical to specify in the protocol the precise definition of the primary variable as it will be used in the statistical analysis. In addition, the clinical relevance of the specific primary variable selected and the validity of the associated measurement procedures will generally need to be addressed and justified in the protocol.The primary variable should be specified in the protocol, along with the rationale for its selection. Redefinition of the primary variable after unblinding will almost always be unacceptable, since the biases this introduces are difficult to assess. When the clinical effect defined by the primary objective is to be measured in more than one way, the protocol should identify one of the measurements as the primary variable on the basis of clinical relevance, importance, objectivity, and/or other relevant characteristics, whenever such selection is feasible.Statistical Principles for Clinical TrialsSecondary variables are either supportive measurements related to the primary objective or measurements of effects related to the secondary objectives. Their pre-definition in the protocol is also important, as well as an explanation of their relative importance and roles in interpretation of trial results. The number of secondary variables should be limited and should be related to the limited number of questions to be answered in the trial.2.2.3 Composite VariablesIf a single primary variable cannot be selected from multiple measurements associated with the primary objective, another useful strategy is to integrate or combine the multiple measurements into a single or 'composite' variable, using a pre-defined algorithm. Indeed, the primary variable sometimes arises as a combination of multiple clinical measurements (e.g. the rating scales used in arthritis, psychiatric disorders and elsewhere). This approach addresses the multiplicity problem without requiring adjustment to the type I error. The method of combining the multiple measurements should be specified in the protocol, and an interpretation of the resulting scale should be provided in terms of the size of a clinically relevant benefit. When a composite variable is used as a primary variable, the components of this variable may sometimes be analysed separately, where clinically meaningful and validated. When a rating scale is used as a primary variable, it is especially important to address such factors as content validity (see Glossary), inter- and intra-rater reliability (see Glossary) and responsiveness for detecting changes in the severity of disease.2.2.4 Global Assessment VariablesIn some cases, 'global assessment' variables (see Glossary) are developed to measure the overall safety, overall efficacy, and/or overall usefulness of a treatment. This type of variable integrates objective variables and the investigator’s overall impression about the state or change in the state of the subject, and is usually a scale of ordered categorical ratings. Global assessments of overall efficacy are well established in some therapeutic areas, such as neurology and psychiatry.Global assessment variables generally have a subjective component. When a global assessment variable is used as a primary or secondary variable, fuller details of the scale should be included in the protocol with respect to:1) the relevance of the scale to the primary objective of the trial;2) the basis for the validity and reliability of the scale;3) how to utilise the data collected on an individual subject to assign him/her to aunique category of the scale;4) how to assign subjects with missing data to a unique category of the scale, orotherwise evaluate them.If objective variables are considered by the investigator when making a global assessment, then those objective variables should be considered as additional primary, or at least important secondary, variables.Global assessment of usefulness integrates components of both benefit and risk and reflects the decision making process of the treating physician, who must weigh benefit and risk in making product use decisions. A problem with global usefulness variables is that their use could in some cases lead to the result of two products being declared equivalent despite having very different profiles of beneficial and adverse effects. For example, judging the global usefulness of a treatment as equivalent or superior to analternative may mask the fact that it has little or no efficacy but fewer adverse effects. Therefore it is not advisable to use a global usefulness variable as a primary variable. If global usefulness is specified as primary, it is important to consider specific efficacy and safety outcomes separately as additional primary variables.2.2.5 Multiple Primary VariablesIt may sometimes be desirable to use more than one primary variable, each of which (or a subset of which) could be sufficient to cover the range of effects of the therapies. The planned manner of interpretation of this type of evidence should be carefully spelled out. It should be clear whether an impact on any of the variables, some minimum number of them, or all of them, would be considered necessary to achieve the trial objectives. The primary hypothesis or hypotheses and parameters of interest (e.g. mean, percentage, distribution) should be clearly stated with respect to the primary variables identified, and the approach to statistical inference described. The effect on the type I error should be explained because of the potential for multiplicity problems (see Section 5.6); the method of controlling type I error should be given in the protocol. The extent of intercorrelation among the proposed primary variables may be considered in evaluating the impact on type I error. If the purpose of the trial is to demonstrate effects on all of the designated primary variables, then there is no need for adjustment of the type I error, but the impact on type II error and sample size should be carefully considered.2.2.6 Surrogate VariablesWhen direct assessment of the clinical benefit to the subject through observing actual clinical efficacy is not practical, indirect criteria (surrogate variables - see Glossary) may be considered. Commonly accepted surrogate variables are used in a number of indications where they are believed to be reliable predictors of clinical benefit. There are two principal concerns with the introduction of any proposed surrogate variable. First, it may not be a true predictor of the clinical outcome of interest. For example it may measure treatment activity associated with one specific pharmacological mechanism, but may not provide full information on the range of actions and ultimate effects of the treatment, whether positive or negative. There have been many instances where treatments showing a highly positive effect on a proposed surrogate have ultimately been shown to be detrimental to the subjects' clinical outcome; conversely, there are cases of treatments conferring clinical benefit without measurable impact on proposed surrogates. Secondly, proposed surrogate variables may not yield a quantitative measure of clinical benefit that can be weighed directly against adverse effects. Statistical criteria for validating surrogate variables have been proposed but the experience with their use is relatively limited. In practice, the strength of the evidence for surrogacy depends upon (i) the biological plausibility of the relationship, (ii) the demonstration in epidemiological studies of the prognostic value of the surrogate for the clinical outcome and (iii) evidence from clinical trials that treatment effects on the surrogate correspond to effects on the clinical outcome. Relationships between clinical and surrogate variables for one product do not necessarily apply to a product with a different mode of action for treating the same disease.2.2.7 Categorised VariablesDichotomisation or other categorisation of continuous or ordinal variables may sometimes be desirable. Criteria of 'success' and 'response' are common examples of dichotomies which require precise specification in terms of, for example, a minimum percentage improvement (relative to baseline) in a continuous variable, or a ranking categorised as at or above some threshold level (e.g., 'good') on an ordinal rating scale.。

模块二商务谈判口译

模块二商务谈判口译

模块二商务谈判口‎译Learn‎ing Objec‎t ives‎1. To have basic‎under‎s tand‎i ng of busin‎e ss negot‎i atio‎n.2. T o maste‎r the strat‎e gies‎of inter‎p reti‎n g Busin‎e ss Negot‎i atio‎n s.3. To learn‎Memor‎y and Note-takin‎g Skill‎s.Abili‎t y Objec‎t ives‎1. T o famil‎i ariz‎e stude‎n ts with words‎and expre‎ssion‎s for busin‎e ss negot‎i atio‎n s.2. T o enabl‎e stude‎n ts to inter‎p ret for funda‎m enta‎l busin‎e ss negot‎i atio‎n s.任务简介(Task Intro‎d ucti‎o n)商务谈判是‎经济谈判的‎一种,是指不同利‎益群体之间‎,以经济利益‎为目的,通过沟通、协商、妥协、合作、策略等各种‎方式,就双方的商‎务往来关系‎而进行的谈‎判。

按照商务谈‎判的地区范‎围来划分,商务谈判可‎分为国内商‎务谈判和国‎际商务谈判‎。

国内商务谈‎判是国内各‎种经济组织‎及个人之间‎所进行的有‎关商品、劳务和技术‎等的商务谈‎判。

国际商务谈‎判是本国政‎府及各种经‎济组织与外‎国政府及各‎种经济组织‎之间所进行‎的商务谈判‎,是国际商务‎活动中不同‎的利益主体‎,为了达成某‎笔交易,而就交易的‎各项条件进‎行协商的过‎程。

国际商务谈‎判是对外经‎济贸易工作‎中不可缺少‎的重要环节‎。

商务谈判是‎集语言、知识、经验、素质等为一‎体的交流活‎动,它注重政策‎性、技术性和艺‎术性,是口译从业‎人员的用武‎之地,是口译能力‎的全方位展‎示和对口译‎者的高难度‎挑战。

international standard for results management

international standard for results management

international standard for results management 全文共四篇示例,供读者参考第一篇示例:国际禁药机构(World Anti-Doping Agency,简称WADA)的“国际赛果管理标准(International Standard for Results Management,简称ISRM)”是一项旨在确保全球反兴奋剂体系运作顺畅、公正有效的重要标准。

ISRM旨在对运动员在比赛中的兴奋剂检测结果进行管理和处理,确保运动员的权利得到充分保护,同时确保反兴奋剂规则得到有效执行。

本文将详细介绍ISRM的背景、目的、内容及实施情况,以帮助读者更好地了解国际禁药体系在保护体育竞技公平性和运动员权益方面所扮演的重要角色。

一、ISRM的背景国际禁药机构(WADA)成立于1999年,致力于推动全球禁药规则的制定和执行,推动反兴奋剂根本性变革的实施。

随着禁药规则的逐步完善和反兴奋剂工作的加强,赛果管理也成为反兴奋剂体系的重要组成部分。

ISRM于2009年颁布,旨在为各个体育组织提供一个统一标准的赛果管理流程,以确保兴奋剂检测结果的公正、公开和迅速处理。

ISRM的主要目的是确保对兴奋剂检测结果的有效管理和处理,以维护体育竞技的公平性和运动员的权益。

具体目标包括但不限于:1. 确保兴奋剂检测结果的准确性和可靠性;2. 确保赛果管理程序的公正、透明和迅速;3. 确保运动员的合法权益得到充分尊重和保护;4. 促进国际和国内体育组织间的协作和信息共享。

ISRM包括以下几个重要内容:1. 兴奋剂检测结果的处理:ISRM规定了针对兴奋剂检测阳性结果的处理程序,包括通知运动员、准备听证会、成立独立小组审议、裁决结果等步骤。

2. 赛果管理组织:ISRM规定了赛果管理组织的组成和职责,包括赛果管理员、独立听证官、独立评估官等,确保赛果管理程序的公正和独立性。

3. 信息共享和协作:ISRM要求赛果管理组织与各级体育组织和国际禁药机构(WADA)保持信息共享和协作,以确保相关信息的准确传递和充分评估。

表示按照依据根据的英语表达

表示按照依据根据的英语表达

“根据,依据、按照”的表达在英‎文合同中使‎用非常频繁‎,特别是重要‎的责任义务‎条款和规定‎,要么依据法‎律法规,要么依据本‎合同其他条‎款的相应规‎定。

因此,必须对此类‎表达非常明‎确,不可含糊。

常用的表达‎方式有:in accor‎d ance‎with; under‎; pursu‎a nt to,accor‎d ing to, subje‎c t to,on the basis‎of 等等。

例中标人的投‎标保证金,在中标人按‎本须知第3‎4条规定签‎订合同,按本须知第‎35条规定‎交纳了履约‎保证金,并按本须知‎第36条规‎定交纳了招‎标服务费后‎予以退还。

The succe‎s sful‎Bidde‎r’s bid secur‎i ty wi11 be disch‎a rged‎upon the Bidde‎r signi‎n g the contr‎a ct, pursu‎a nt to ITB Claus‎e34, and furni‎s hing‎the perfo‎r manc‎e secur‎i ty, pursu‎a nt to ITB Claus‎e 35,and payme‎n t of Tende‎r ing servi‎c e fee pursu‎a nt to ITB Claus‎e 36.例 Agenc‎y shall‎not comme‎n ce work on any proje‎c t pursu‎a nt to this Agree‎m ent witho‎u t first‎estim‎a ting‎costs‎for prepa‎r atio‎n, inclu‎d ing copy, servi‎c e layou‎t, art, engra‎v ing, typog‎r aphy‎, proce‎s sing‎,paste‎up and produ‎c tion‎.After‎deter‎m inin‎g the estim‎a ted cost, compl‎e tion‎of the work shall‎be subje‎c t to Adver‎t iser‎’s prior‎appro‎v al.根据此协议‎,代理商不可‎以不进行任‎何费用评估‎就开始对任‎何项目的工‎作,包括:复印,服务设计,版画,版面设计,加工,粘贴和生产‎。

11077 UCB将在欧洲推出严重过敏反应的应急治疗

11077 UCB将在欧洲推出严重过敏反应的应急治疗

11077 UCB将在欧洲推出严重过敏反应的应急治疗
刘敏(摘)
【期刊名称】《国外药讯》
【年(卷),期】2006(000)011
【摘要】UCB公司获得由Verus公司开发的严重过敏反应应急治疗用肾上腺素自动注射器Twinject的欧洲销售权。

去年,这种产品已被投放到美国和加拿大市场,是唯一获准于一个紧凑的单个自我给药装置内含两个剂量肾上腺素的产品。

与其他应急肾上腺素治疗不同,Twinject是一个双份包装,因为研究表明,过敏反应的
恰当治疗通常需要第二次给药。

然而,这样一种双剂量治疗在欧洲还没有问世。

【总页数】1页(P34)
【作者】刘敏(摘)
【作者单位】无
【正文语种】中文
【中图分类】R781.31
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BELIZE:INTERNATIONAL BUSINESS COMPANIES (AMENDMENT)ACT, 2017ARRANGEMENT OF SECTIONS1.Short title.2.Amendment of section 2.3.Amendment of section 5.4.Amendment of section 9.5.Amendment of section 11.6.Amendment of section 12.7.Amendment of section 16.8Amendment of section 31.9.Repeal and replacement of section 34.10.Amendment of section 41.11.Amendment of section 45.12.Amendment of section 49.13.Amendment of section 69.14.Amendment of section 71.15.Insertion of new Part VI A.16.Amendment of section 96.17.Amendment of section 102.18.Amendment of section 103.19Amendment of section 107.20.Amendment of section 108.21.Amendment of section 111.22.Amendment of section 113.23.Repeal and replacement of Part XII.24.Insertion of section 133A.25.Amendment of section 151.26.Transitional.AN ACT to amend the International Business CompaniesAct, Chapter 270 of the Laws of Belize, RevisedEdition 2011; to prohibit the issuance of bearershares in an international business company; toprovide for Register of Directors and Register ofBeneficial Owners and for such Registers to be keptat the registered office in Belize; to provide for theRegisters upon request by the competent authorityto be produced within twenty-four hours; to repealprovisions relating to tax exemptions and providefor the optional payment of income and businesstax by an international business company; and toprovide for matters connected therewith or incidentalthereto.(Gazetted 22nd July, 2017.)1.This Act may be cited as the INTERNATIONAL BUSINESS COMPANIES(AMENDMENT) ACT 2017,Short title.No. 36 of 2017I assent,(SIR COLVILLE N. YOUNG)Governor-General21st July, 2017.and shall be read and construed as one with the International Business Companies Act , which, is hereinafter referred toas the principal Act.2.The principal Act is being amended in section 2(1) to insert the following definitions -a)“Approved Stock Exchange” means the International Stock Exchange of the United Kingdom and the Republic of Ireland Limited (including the Unlisted Security Market of the International Stock Exchange), the New York Stock Exchange, the American Stock Exchange, the National Association of Securities Dealers’ Automated Quotation System of the United States of America or any other stock exchange approved for this purpose by the Minister.b)“beneficial owner” means the natural person–(a)who ultimately owns or controls a customer;(b)on whose behalf a transaction is being conducted; or (c)who exercise ultimate effective control over a legal person or arrangement; and c)“register of beneficial owners” means the register of beneficial owners pursuant to section 82B.d)“ultimately owns or controls” and “ultimate effective control” refer to situations in which ownership or control is exercised through a chain of ownership or by means of control other than direct control.Cap. 270.S.I. 11/2016.S.I. 39/2016.Amendment of section 2.3.The principal Act is amended in section 5(2)(f) by deleting the words “Registration of Merchant Ships Act”and substituting the words “Merchant Ships (Registration) Act”.4.The principal Act is amended in section 9 –(a)in subsection (1)(a)by deleting the words “orshares issued to bearer or both” and substitutingthe word “only.”; and(b)by inserting the following new subsectionsimmediately after subsection (1) –“(1A)Any company that has shares listed forquotation on an Approved StockExchange list may by notice in writingrequire any member of the companywithin such reasonable time as isspecified in the noticeto inform it —(a)whether he holds any voting sharesin the company as beneficial owneror as trustee; and(b)if he hold such voting shares astrustee, to indicate the persons forwhom he holds them by name andby other particulars to enablethose persons to be identified andthe nature of their interest.(1B)Where a company is informed inpursuance of a notice given to anyperson under subsection (1A) or underthis subsection that any other personhas an interest in any of the votingshares in a company, the company may Amendment of section 5. Amendment of section 9.by notice in writing require that other person within such reasonable time as is specified in the noticeto inform it —(a)whether he holds that interest as beneficial owner or as trustee;and (b)if he holds such interest as trustee,to indicate the persons for whom he holds it by name and by other particulars to enable those persons to be identified and the nature of their interest.(1C) Any company to which this section applies may by notice in writing require any member of the company to inform it, within such reasonable time as is specified in the notice, whether any of the voting rights carried by any voting shares in the company held by him are the subject of an agreement or arrangement under which another person is entitled to control his exercise of those rights and, if so, to give particulars of the agreement or arrangement and the parties to it.”1D) A notice under subsection (1A), (1B)or (1C) may be sent either generally to members of the company concerned or to one or more particular members,and may be sent electronically.”.5.The principal Act is amended in section 11–(a)in subsection (1) by deleting the word “Society”and substituting the word “Société”;Amendment of section 11.(b)in subsection (3)(i)by deleting from paragraph (a) the words“except where the company in existencegives its consent”;(ii)by inserting in paragraph (b) immediately after the word “Imperial”, the word“Monarchy”;(iii)by deleting paragraph (d) and substituting the following–“(d)contains any one or more of thewords “Academy”, “AssetManagement”, “Assurance”,“Bank”, “Brokerage”, “CreditUnion”, “Education”, “Fiduciary”,“Financial”, “Foreign Exchange”,“Forex”, “Fund”, “InvestmentManagement”, “Insurance”,“Lending”, “Securities”, “Trust”,or “University” or any of theirderivatives or cognate expressions,unless it is licensed under theenactment or enactments thatauthorize it to carry on the businessor activities associated with theword or words, so contained”;(iv) by inserting after paragraph (d) the following as paragraph (e) –“(e)contains the top level domain suchas “.com”, “.org”, “.net” or “.bz”of a domain name.”(c)by inserting after subsection (3) the followingas subsection (3A) -“(3A)The Registrar may, by Order published in the Gazette , modify the list of words specified in subsection (3)(d ) to which the business or activities of a company may be associated, by, among other things, adding words or abbreviations to the list.”(d)in subsection (5) by inserting after the word,“Gazette ” a comma and the words “the website of the Registrar or other publication of general circulation in Belize.”;(e)by inserting after subsection (8) the following as subsection (9) -“(9)Despite anything contained in this section,an international business company that is continued under this Act –(a)shall be continued with the name it lawfully had before that continuance if there is no other company registered under this Act or the Companies Act in that name; and (b)may only submit to the Registrar a request for the consideration of a change of name after a period of six months has elapsed from the date of continuation pursuant to section 92.6.The principal Act is amended in section 12(1) by deleting paragraphs (i),(j) and (k)and substituting thefollowing –“(i) a statement that the company is prohibited bythis or any other enactment from issuingCAP. 250.Amendment of section 12.bearer shares, and that the company is not authorised to,(a)issue bearer shares;(b)convert registered shares to bearer shares;or(c)exchange registered shares for bearershares;”.7.The principal Act is amended in section 16(2) by inserting immediately after the word “Registrar” where it first appears, the words “along with an authenticated copy of the resolution passed or other authenticated documents, to the satisfaction of the Registrar that the amendment was duly authorised”.8.The principal Act is amended in section 31(1)–(a)in paragraph (c), by inserting after the words,“share register;” the word “and”;(b)in paragraph (d), by deleting the semi colon atthe end of the paragraph and substituting a fullstop;(c)by deleting paragraphs (e) and (f).9.The principal Act is amended by repealing section 34 and substituting the following–“34.A company shall not issue bearer share, convertregistered shares to bearer shares nor exchangeregistered shares for bearer shares, and every companywho contravenes this provision commits an offenceand shall be liable on summary conviction to a fineof $5,000.00 for each day of such failure to comply”.Amendment of section 16. Amendment of section 31.Repeal and replacement of section 34. Bearer shares prohibited.10.The principal Act is amended in section 41–(a)in subsection (1) by deleting the words, “bearer share or the”; and (b)by deleting subsection (2).11.The principal Act is amendment in section 45–(a)in subsection (2) by deleting the words “in the Gazette ” and substituting the words “on the website of the Registrar”;(b)in subsection (4)(c)–(i)after the word “Gazette ” first appearance,insert a comma and the words “the website of the Registrar or other publication of general circulation in Belize”; and (ii)after the word “Gazette ,” second appearance, insert the words “website or other publication,”.(c)in subsection (4)(d), after the word “Gazette ”by inserting a comma and the words “the website of the Registrar or other publication of general circulation in Belize”.12.The principal Act is amended in section 49–(a)in the marginal note by deleting the words“Optional register” and substituting the word “Register”; and(b)by deleting subsection (1) and substituting thefollowing –Amendment ofsection 41.Amendment ofsection 45.Amendment of section 49.“(1)A company incorporated under this Act shall keep a register to be known as aregister of directors containing thefollowing particulars –(a)in the case of an individual director,the individual’s –(i)full name;(ii)former name, if any, unlessthe former name was changedby deed poll or other legalmeans or disused for morethan 10 years;(iii)usual residential address,unless that address is the sameas the individual’s address forthe service of documents;(iv)address for the service ofdocuments;(v)date of birth;(vi)nationality;(vii)occupation;(viii)date of appointment asdirector;and(ix)date of cessation as director(b)in the case of a corporate director,the corporate director’s –(i)corporate name;(ii)corporate or registrationnumber, if any;(iii)registered office or principaloffice;(iv)address, but if the corporatedirector is incorporated orregistered in Belize, itscorporate or registrationnumber only;(v)place of incorporation orregistration and date ofsuchincorporation orregistration;(vi)date of appointment asdirector'(vii)date of cessation as director;and(c)such other information as may beprescribed.”(c)by inserting after subsection 3 the followingas subsections (4) and (5) –“(4)The register of directors is prima facie evidence of any matters directed orauthorised by this Act to be containedtherein.(5) A company thatcontravenes this sectionis liable to a penalty of $25 for each dayor part thereof during which thecontravention continues, and a directorwho knowingly permits thecontravention is liable to a like penalty.”13.The principal Act is amended in section 69–(a)in subsection (1) by deleting the words “depositbearer shares with, or”; and(b)in paragraph(e) by deleting the words, “in thecase of registered shares and the certificates incase of bearer shares”.14.The principal Act is amended in section 71—(a)deleting subsection (1) and substituting thefollowing —“(1) Any notice, information or written statement required under this Act to be given by acompany incorporated under this Act to membersmust be served, in the case of members holdingregistered shares,(a)in the manner prescribed in thememorandum or Articles, as the casemay be; or(b)in the absence of a provision in theMemorandum or Articles, by personalservice of by mail addressed to eachmember at the address shown in theshare register.”; and(b) by deletingsubsections (2) and (3).15.The principal Act is amended by inserting the following as new Part VI A after section 82 –Amendment of section 69. Amendment of section 71.Insertion of new Part VI A.“PART VI ABeneficial Owners 82B. (1) A company incorporated under this Act shall keep a register to be known as the register of beneficialowners containing the following particulars –(a)full name;(b)former name, if any, unless the former namewas changed by deed poll or other legal meansor disused for more than 10 years;(c)date on which the person became a beneficialowner;(d)date on which the person ceasedto be abeneficial owner;(e)usual residential address, unless that address isthe same as the individual’s address for theservice of documents;(f)date of birth;(g)nationality;(h)occupation;(i)particulars of each beneficial owner’s beneficialinterest and how it is held; and(j)such other information as may be prescribed.(2)The directors shall ensure that the information required by subsection (1) to be kept in its register of beneficial owners is accurate and up-to-date.Register ofbeneficial owners.(3)The register of beneficial owners may be in such form as the director may approve but if it is in magnetic, electronic or other date storage form, the company must be able to produce legible evidence of its contents.(4)The register of beneficial owners is prima facie evidence of any matters directed or authorised by this Act to be contained therein.(5)An entry relating to a former beneficial owner of the company may be removed from the register of beneficial owners after 5 years from the date on which that person ceased to be a beneficial owner of the company.(6)A company that contravenes this section is liable to a penalty of $500 for each day or part thereof during which the contravention continues, and a director who knowingly permits the contravention is liable to a like penalty.82C. (1) A beneficial owner of a company incorporated under this Act may, in person or by attorney and in furtherance of a proper purpose, request in writing, specifying the purpose, to inspect during normal business hours the register of beneficial owners of the company and to make copies or extracts therefrom.(2) For the purposes of subsection (1) of this section,a proper purpose is a purpose reasonably related to the beneficial owner’s interest.(3)If a request under subsection (1) of this section is submitted by an attorney, the request must be accompanied by a power of attorney authorising the attorney to act for the beneficial owner.(4)If the company, by a resolution of directors, determines that it is not in the best interest of the company Inspection of register of beneficial owners.or of any other member of the company to comply with a request under subsection (1) of this section, the company may refuse the request.(5)Upon refusal by the company of a request under subsection (1) of this section, the beneficial owner may,before the expiration of a period of 90 days of his receiving notice of the refusal, apply to the court for an order to allow the inspection.82D. (1)If -(a)information that is required to be enteredin the register of beneficial owners undersection 82B (1) of this Act, is omittedtherefrom or inaccurately entered therein;or(b)there is unreasonable delay in entering theinformation in the register of beneficial owners,a beneficial owner of the company, or any person who is aggrieved by the omission, inaccuracy or delay, may apply to the court for an order that the register of beneficial owners be rectified, and the court may either grant or refuse the application, with or without costs to be paid by the applicant, or order the rectification of the register of beneficial owners, and may direct the company to pay all costs of the application and any damages the applicant may have sustained.(2) The court may, in any proceedings under subsection (1) of this section, determine any question relating to the right of a person who is a party to the proceedings to have his name entered in or omitted from the register of beneficial owners, whether the question arises between -Rectificationof register ofbeneficial owners.(a)two or more members or allegedmembers; or(b)between members or allegedmembers and the company, and generally the court may in the proceedings determine any question that may be necessary or expedient to be determined for the rectification of the register of beneficial owners.82E. (1)Subject to subsection (2), a company to which section 82B (1) applies shall identify each beneficial owner of the company.(2)A company to which section 82B applies shall give written notice to anyone whom it knows or has reasonable cause to believe to be a beneficial owner in relation to it, which notice shall require that person –(a)to state whether or not he is a beneficial ownerin relation to the company; and(b)if so, as applicable to provide, confirm orcorrect the registable particulars relating tohim.(3)A company to which section 82B applies shall give written notice to anyone whom it knows or has reasonable cause to believe that such person knows the identity of a person who is a beneficial owner in relation to it, which notice shall require that person –(a)to state whether or not he knows the identityof a beneficial owner in relation to the companyor knows the identity of any person likely tohave that knowledge; and Company’s duty to seek beneficial ownership information.(b)if so, supply any particulars of such persons that are within the knowledge of the person notified.(4)Without limiting subsections (2) and (3), a company may at any time give written notice to a member of the company to provide, confirm or correct the information supplied under section 82B in relation to the shares or guarantee membership interest in the company held by the member.(5)A notice under this section shall state that the person to be notified must comply with the notice within thirty days commencing from the date of the notice.(6)A company is not required to take steps or give notice under this section with respect to a beneficial owner if the company has already been informed in writing of the person’s status as a beneficial owner in relation to it,and has been supplied with the information under section 82B.(7)A company that fails to comply with subsections (2) or (3), commits an offence and is liable on summary conviction to a fine of $50,000.00.82F. (1)Within 30 days of a person becoming a beneficial owner in relation to a company, he shall give written notice to the company of the information requiredpursuant to section 82B.(2)If there is a change in any information provided to the company in relation to a beneficial owner, that beneficial owner shall give written notice to such change to the company and the date on which the change occurred.(3)A person shall not provide false or misleading information under this section.Updating ofbeneficialownership information.(4)A person who contravenes this section commits an offence and is liable on summary conviction to a fine of $50,000.00.”16.The principal Act is amended in section 96(4)(c) after the word “Gazette” by inserting a comma and the words “the website of the Registrar or other publication of general circulation in Belize”.17.The principal Act is amended in section 102–(a)in subsection (4) after the word “Gazette” byinserting the words “ or the website of theRegistrar,”; and(b)in subsection (8) after the word “Gazette” byinserting the words “ or the website of theRegistrar,”.18.The principal Act is amended in section 103(3) after the word “Gazette” by inserting the words “ or the website of the Registrar,”.19.The principal Act is amended in section 107–(a)in subsection (3) after the word “Gazette” byinserting a comma and the words “the websiteof the Registrar or other publication of generalcirculation in Belize”;(b)in subsection (4) by deleting the words “publishin the Gazette” and substituting the words“publish in the website of the Registrar orother publication of general circulation inBelize”.20.The principal Act is amended in section 108(3) by deleting the words, “within 3 years” and substituting “within 5 years”.Amendment of section 96. Amendment of section 102.Amendment of section 103. Amendment of section 107.Amendment of section 108.21.The principal Act is amended in section 111(2)(b)after the word “Gazette ” by inserting the words “ or the website of the Registrar,”.22.The principal Act is amended in section 113 by inserting the following as new paragraphs immediately after paragraph (v) –“(w)$25 upon the approval by the Registrar for publication of a document on the website of the IBC Registry;(x)$25 upon the change of details kept by the Registrar in the register of registered agents.”23.The principal Act is amended by deleting Part XII and substituting the following as new Part XII –“PART XII Income Tax And Other Taxes, Duties And Exchange Control Restrictions 130. (1)An international business company may elect—(a)to be exempted from taxes under the Incomeand Business Tax Act; or(b)to be liable to taxes under the Income andBusiness Tax Act relating to the profits andgains of theinternational business company atthe rate specified in subsection (6).(2)Notwithstanding any provisions of the Income and Business Tax Act an internationalbusiness company that elects to be exempt from tax undersubsection (1)(a)Amendment ofsection 111.Amendment ofsection 113.Repeal andreplacement ofPart XII.Income tax and other taxes.shall not be required to file any tax returns,but an international business company that elects to pay taxunder subsection (1)(b) shall file an annual tax return based on annual financial statements.(3)An international business company shall not be subject towithholding, capital gains or other like taxes except for taxes for an international business company making an election asprovided for in subsection (1)(b).(4)For purposes of this Part, an international business companyshall not be considered to be doing business in Belize solely because it engages in one or more of the activities specified in section 5(2).(5)Notwithstanding, any provision of the Stamp Duty Act to the contrary—(a)an instrument relating to transfers of anyproperty to or byan international businesscompany;(b)an instrument relating to transactions in respectof theshares, debt obligations or other securitiesof aninternational business company; or(c)an instrument relating in any way to the assetsoractivities of an international businesscompany,is exempt from the payment of stamp duty.(6)Pursuant to subsection (1)(b), there shall be levied and paid to the Commissioner of Income Tax, a tax at the rate prescribed by the Minister.CAP. 64. CAP. 55.130A.Any dividend paid or distributedby an international businesscompany, which does no business in Belize, to anotherinternational business company, or to persons, trusts or other entitieswhich are not residents, shall be exempt from any tax or withholdingprovisions of the law in force in Belize which would otherwisebe applicable to the international business company or to the recipientof the dividend or distribution.”24.The principal Act is amended by inserting the following new section 133A immediately after section 133 –“133A. (1) Any registers required to be kept by a company shall be kept at the registered office, and upon a request made by the competent authority, the registered agent shall produce the requested registers within twenty-four hours of the date of receipt of the request.(2) For the purposes of subsection (1)“competent authority” means the International Financial Services Commission established under the International Financial Services Commission Act or other authority so designated, recognized or appointed under an enactment.”25.The principal Act is amended in section 151(2) after the word “Gazette ” by inserting the words “ or the website of the Registrar,”.26.(1)Every company which has issued bearershares shall, within one year from the date of commencementof this Act, convert such shares into registered sharesand cancel all bearer share certificates issued (if any).Exemption fordividends anddistributions.Insertion ofsection 133A.Production of registers.CAP. 272.Amendment ofsection 151.Transitional.(2)Any bearer shares which have not been converted and cancelled within the said period of one year pursuant to subsection (1) shall thereafter be null and void and be without effect for all purposes of law.(3)Where a company which has been in existence prior to the commencement of this Act, fails to comply with section 12(1)(i) within one year from the date of commencement of this Act, as of 1st July 2018 such company shall be deemed to have amended its memorandum in accordance with said section 12(1)(i) and any reference to bearer shares in the company’s memorandum shall be null and void.(4)Every company which has been in existence prior to the commencement of this Act shall, within one year from the date of commencement of this Act, file its register of directors and register of beneficial owners at the registered office.Printed in Belize by the Government Printer。

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