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SUBJECTSUBJECT
PRINCIPLES OFPRINCIPLES OFMANAGEMENTMANAGEMENT
TERM PAPERTERM PAPER
ONONRole of workers inRole of workers in
pharmaceuticals industriespharmaceuticals industries
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INTRODUCTIONINTRODUCTION
The earliest drugstores date back to the MiddleThe earliest drugstores date back to the Middle
Ages. The first known drugstore was opened byAges. The first known drugstore was opened by
Arabian pharmacists in Baghdad in 754,[2] andArabian pharmacists in Baghdad in 754,[2] and
many more soon began operating throughout themany more soon began operating throughout themedieval Islamic world and eventually medievalmedieval Islamic world and eventually medieval
Europe. By the 19th century, many of the drugEurope. By the 19th century, many of the drug
stores in Europe and North America hadstores in Europe and North America had
eventually developed into larger pharmaceuticaleventually developed into larger pharmaceuticalcompanies.companies.
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Most of today's major pharmaceuticalMost of today's major pharmaceuticalcompanies were founded in the late 19thcompanies were founded in the late 19thand early 20th centuries. Key discoveries ofand early 20th centuries. Key discoveries of
the 1920s and 1930s, such as insulin andthe 1920s and 1930s, such as insulin andpenicillin, became masspenicillin, became mass--manufactured andmanufactured anddistributed. Switzerland, Germany anddistributed. Switzerland, Germany andItaly had particularly strong industries,Italy had particularly strong industries,with the UK, US, Belgium and thewith the UK, US, Belgium and theNetherlands following suit.Netherlands following suit.
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Legislation was enacted to test and approve drugsLegislation was enacted to test and approve drugsand to require appropriate labelling. Prescriptionand to require appropriate labelling. Prescriptionand nonand non--prescription drugs became legallyprescription drugs became legally
distinguished from one another as thedistinguished from one another as thepharmaceutical industry matured. The industrypharmaceutical industry matured. The industrygot underway in earnest from the 1950s, due to thegot underway in earnest from the 1950s, due to thedevelopment of systematic scientific approaches,development of systematic scientific approaches,understanding of human biology (including DNA)understanding of human biology (including DNA)and sophisticated manufacturing techniques.and sophisticated manufacturing techniques.
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Numerous new drugs were developedNumerous new drugs were developedduring the 1950s and massduring the 1950s and mass--produced andproduced andmarketed through the 1960s. These includedmarketed through the 1960s. These included
the first oral contraceptive, "The Pill",the first oral contraceptive, "The Pill",Cortisone, bloodCortisone, blood--pressure drugs and otherpressure drugs and otherheart medications. MAO Inhibitors,heart medications. MAO Inhibitors,chlorpromazine (Thorazine), Haldolchlorpromazine (Thorazine), Haldol(Haloperidol) and the tranquilizers ushered(Haloperidol) and the tranquilizers usheredin the age of psychiatric medicationin the age of psychiatric medication
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Valium (diazepam), discovered in 1960, wasValium (diazepam), discovered in 1960, was
marketed from 1963 and rapidly became the mostmarketed from 1963 and rapidly became the most
prescribed drug in history, prior to controversyprescribed drug in history, prior to controversy
over dependency and habituation.over dependency and habituation.
Attempts were made to increase regulation and toAttempts were made to increase regulation and to
limit financial links between companies andlimit financial links between companies and
prescribing physicians, including by the relativelyprescribing physicians, including by the relatively
new U.S. Food and Drug Administration (FDA).new U.S. Food and Drug Administration (FDA).
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Such calls increased in the 1960s after theSuch calls increased in the 1960s after thethalidomide tragedy came to light, in which thethalidomide tragedy came to light, in which theuse of a new tranquilizer in pregnant womenuse of a new tranquilizer in pregnant womencaused severe birth defects. In 1964, the Worldcaused severe birth defects. In 1964, the World
Medical Association issued its Declaration ofMedical Association issued its Declaration ofHelsinki, which set standards for clinical researchHelsinki, which set standards for clinical researchand demanded that subjects give their informedand demanded that subjects give their informedconsent before enrolling in an experiment.consent before enrolling in an experiment.Phamaceutical companies became required toPhamaceutical companies became required toprove efficacy in clinical trials before marketingprove efficacy in clinical trials before marketingdrugs.drugs.
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Cancer drugs were a feature of the 1970s. From 1978, India took overCancer drugs were a feature of the 1970s. From 1978, India took overas the primary center of pharmaceutical production without patentas the primary center of pharmaceutical production without patentprotection.[citation needed] The industry remained relatively smallprotection.[citation needed] The industry remained relatively smallscale until the 1970s when it began to expand at a greater rate.[citationscale until the 1970s when it began to expand at a greater rate.[citationneeded] Legislation allowing for strong patents, to cover both theneeded] Legislation allowing for strong patents, to cover both the
process of manufacture and the specific products, came in to force inprocess of manufacture and the specific products, came in to force inmost countries. By the midmost countries. By the mid--1980s, small biotechnology firms were1980s, small biotechnology firms werestruggling for survival, which led to the formation of mutuallystruggling for survival, which led to the formation of mutuallybeneficial partnerships with large pharmaceutical companies and abeneficial partnerships with large pharmaceutical companies and ahost of corporate buyouts of the smaller firms. Pharmaceuticalhost of corporate buyouts of the smaller firms. Pharmaceuticalmanufacturing became concentrated, with a few large companiesmanufacturing became concentrated, with a few large companiesholding a dominant position throughout the world and with a fewholding a dominant position throughout the world and with a few
companies producing medicines within each country.companies producing medicines within each country.
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The pharmaceutical industry entered the 1980sThe pharmaceutical industry entered the 1980s
pressured by economics and a host of newpressured by economics and a host of new
regulations, both safety and environmental, butregulations, both safety and environmental, but
also transformed by new DNA chemistries andalso transformed by new DNA chemistries andnew technologies for analysis andnew technologies for analysis and
computation.[citation needed] Drugs for heartcomputation.[citation needed] Drugs for heart
disease and for AIDS were a feature of the 1980s,disease and for AIDS were a feature of the 1980s,
involving challenges to regulatory bodies and ainvolving challenges to regulatory bodies and afaster approval process.faster approval process.
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Managed care and Health maintenance organizationsManaged care and Health maintenance organizations(HMOs) spread during the 1980s as part of an effort to(HMOs) spread during the 1980s as part of an effort tocontain rising medical costs, and the development ofcontain rising medical costs, and the development ofpreventative and maintenance medications became morepreventative and maintenance medications became moreimportant. A new business atmosphere becameimportant. A new business atmosphere becameinstitutionalized in the 1990s, characterized by mergersinstitutionalized in the 1990s, characterized by mergersand takeovers, and by a dramatic increase in the use ofand takeovers, and by a dramatic increase in the use ofcontract research organizations for clinical developmentcontract research organizations for clinical developmentand even for basic R&D. The pharmaceutical industryand even for basic R&D. The pharmaceutical industryconfronted a new business climate and new regulations,confronted a new business climate and new regulations,
born in part from dealing with world market forces andborn in part from dealing with world market forces andprotests by activists in developing countries. Animal Rightsprotests by activists in developing countries. Animal Rightsactivism was also a challenge.activism was also a challenge.
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Marketing changed dramatically in the 1990s, partlyMarketing changed dramatically in the 1990s, partlybecause of a new consumerism.[citation needed] Thebecause of a new consumerism.[citation needed] TheInternet made possible the direct purchase of medicines byInternet made possible the direct purchase of medicines bydrug consumers and of raw materials by drug producers,drug consumers and of raw materials by drug producers,
transforming the nature of business. In the US, Directtransforming the nature of business. In the US, Direct--toto--consumer advertising proliferated on radio and TVconsumer advertising proliferated on radio and TVbecause of new FDA regulations in 1997 that liberalizedbecause of new FDA regulations in 1997 that liberalizedrequirements for the presentation ofrequirements for the presentation of
risks. The new antidepressants, the SSRIs, notablyrisks. The new antidepressants, the SSRIs, notably
Fluoxetine (Prozac), rapidly became bestsellers andFluoxetine (Prozac), rapidly became bestsellers andmarketed for additional disorders.marketed for additional disorders.
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Drug development progressed from a hitDrug development progressed from a hit--andand--missmissapproach to rational drug discovery in both laboratoryapproach to rational drug discovery in both laboratorydesign and naturaldesign and natural--product surveys. Demand forproduct surveys. Demand fornutritional supplements and sonutritional supplements and so--called alternativecalled alternative
medicines created new opportunities and increasedmedicines created new opportunities and increasedcompetition in the industry. Controversies emergedcompetition in the industry. Controversies emergedaround adverse effects, notably regarding Vioxx in the US,around adverse effects, notably regarding Vioxx in the US,and marketing tactics. Pharmaceutical companies becameand marketing tactics. Pharmaceutical companies becameincreasingly accused of disease mongering or overincreasingly accused of disease mongering or over--
medicalizing personal or social problems.medicalizing personal or social problems.
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ROLE OF EMPLOYEESROLE OF EMPLOYEES
The pharmaceutical industry may be considered as aThe pharmaceutical industry may be considered as aspecial section of the chemical industry in which manyspecial section of the chemical industry in which manynatural and synthetic agents are used to producenatural and synthetic agents are used to producetherapeutically active products for human consumption.therapeutically active products for human consumption.Some of its final products have potentially serious sideSome of its final products have potentially serious sideeffects and virtually all are biologically active. Reports ofeffects and virtually all are biologically active. Reports ofoccupationally related health problems within the industryoccupationally related health problems within the industrydate back nearly 40 years, and in his early review of thedate back nearly 40 years, and in his early review of thesubject Watrous outlined the hazards of handling "crudesubject Watrous outlined the hazards of handling "crudevegetable drugs," solvents, and the byproducts of organicvegetable drugs," solvents, and the byproducts of organic
synthesis.' Since then, various illnesses associated withsynthesis.' Since then, various illnesses associated withdrug manufacture have been reported. These includedrug manufacture have been reported. These include
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allergies,allergies,
liver disordersliver disorders
adrenocortical suppression,adrenocortical suppression,
feminization syndromesfeminization syndromes
In addition, certainIn addition, certain
Chemotherapeutic agents produced to combat malignancyChemotherapeutic agents produced to combat malignancy
may themselves carry a risk of neoplasia.may themselves carry a risk of neoplasia.
The jobs in these industries were grouped as:The jobs in these industries were grouped as: ManagersManagers
SupervisersSupervisers
OperativesOperatives
Laboratory quality assistantsLaboratory quality assistants
Maintenance/engineersMaintenance/engineers Clerical/admininstrativeClerical/admininstrative
Sales representativesSales representatives
AncilliaryAncilliary
UnspecifiedUnspecified
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ROLE AND DUTIES (Sales Manager)ROLE AND DUTIES (Sales Manager)
A pharmaceutical company sales managerA pharmaceutical company sales managersupervises a sales team of pharmaceutical salessupervises a sales team of pharmaceutical salesrepresentatives who represents a drug company torepresentatives who represents a drug company toclinics, hospitals, private practice doctors, andclinics, hospitals, private practice doctors, and
other medical organizations. Managers areother medical organizations. Managers areresponsible for distribution strategies, regionalresponsible for distribution strategies, regionalsales teams, marketing and advertising strategiessales teams, marketing and advertising strategiesand reporting to senior management (concerningand reporting to senior management (concerningsales targets and goals). A pharmaceuticalsales targets and goals). A pharmaceutical
manager also creates a network with potentialmanager also creates a network with potentialbuyers for products.buyers for products.
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ANALYSIS OF THE WORKINGANALYSIS OF THE WORKING
CONDI
TI
ONSCONDI
TI
ONS The 1961 and 1971 cohorts comprised 1472 andThe 1961 and 1971 cohorts comprised 1472 and
2102 employees respectively and both were2102 employees respectively and both were
followed up to the end of 1981. The trace rates forfollowed up to the end of 1981. The trace rates for
the two cohorts were 90.0% (1961) and 96the two cohorts were 90.0% (1961) and 96--1%1%(1971). Up to the end of 1981 657 deaths occurred(1971). Up to the end of 1981 657 deaths occurred
in the two cohorts. In the 20 years covered by thein the two cohorts. In the 20 years covered by the
study for the 1961 cohort 350 men died whereasstudy for the 1961 cohort 350 men died whereas
428428--9 would have been expected on the basis of9 would have been expected on the basis ofnational rates (table 1).national rates (table 1).
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Similar deficits were noted for the 1971 cohortSimilar deficits were noted for the 1971 cohort
with a marginally lower O/E ratio of 0with a marginally lower O/E ratio of 0--7777
(compared with 0(compared with 0--81 for the 1961 cohort). The81 for the 1961 cohort). The
only excesses noted in cells containing five or moreonly excesses noted in cells containing five or moredeaths were for cancer of the large intestine (0:7;deaths were for cancer of the large intestine (0:7;
E:4 4) and suicide (0:5; E:2E:4 4) and suicide (0:5; E:2--5) both in the 19715) both in the 1971
cohort. Otherwise, there were deficits in mortalitycohort. Otherwise, there were deficits in mortality
or the subgroupings produced observed numbersor the subgroupings produced observed numbersof deaths of less than 5.of deaths of less than 5.
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For women a similar pattern of mortalityFor women a similar pattern of mortality
deficits emerged with the exception ofdeficits emerged with the exception of
"accidents/violence" in the 1961 cohort"accidents/violence" in the 1961 cohort
(0:6; E:2(0:6; E:2--4) (table 2). Excesses were present4) (table 2). Excesses were present
for cancer of the large intestine but thefor cancer of the large intestine but the
numbers were too small to warrant formalnumbers were too small to warrant formal
statistical testing.statistical testing.
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In short, there was a consistent deficit for mostIn short, there was a consistent deficit for mostcauses of death analysed, whereas where excessescauses of death analysed, whereas where excessesoccurred they were either not restricted to specificoccurred they were either not restricted to specific
job or industry groupings or were too few tojob or industry groupings or were too few towarrant statistical analysis. Whereas the presentwarrant statistical analysis. Whereas the presentstudy is not confined to employed people, thestudy is not confined to employed people, thesamples selected included a higher proportion ofsamples selected included a higher proportion ofemployed people than was to be found in theemployed people than was to be found in the
national population at a comparable time.national population at a comparable time.
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ROLE OF TRADE UNIONSROLE OF TRADE UNIONS
The trade unions have played a very vitalThe trade unions have played a very vital
role to improve the working conditions ofrole to improve the working conditions of
the workers there, various types ofthe workers there, various types of
organizations have also come to help theorganizations have also come to help the
deteoriating working conditions and severaldeteoriating working conditions and several
steps have also been taken to help the causessteps have also been taken to help the causes
which are as follows:which are as follows:
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Companies manufacturing or importing chemicalCompanies manufacturing or importing chemical
substances in quantities of one tonne or more persubstances in quantities of one tonne or more per
year will be required to register them to show thatyear will be required to register them to show that
they can be used safely.they can be used safely.
In addition, Producers of substances of very highIn addition, Producers of substances of very high
concern (like carcinogens or toxins thatconcern (like carcinogens or toxins that
accumulate in the environment) will need toaccumulate in the environment) will need to
obtain authorization before using or placing themobtain authorization before using or placing them
on the market.on the market.
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3M HELPS PHARMACEUTICAL3M HELPS PHARMACEUTICAL
INDUSTRYINDUSTRY
Diversified Technology company 3M hasDiversified Technology company 3M has
introduced a new range of powered andintroduced a new range of powered and
supplied air respiratory protective systemssupplied air respiratory protective systems
which offer workers in the pharmaceuticalwhich offer workers in the pharmaceutical
industry a comprehensive, modularindustry a comprehensive, modular
approach to worker protection.approach to worker protection.
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3Ms Versaflo Respiratory Protective Systems supply3Ms Versaflo Respiratory Protective Systems supplyclean, safe air to the workers breathing zone and soclean, safe air to the workers breathing zone and soallowing them to work comfortably for long periods.allowing them to work comfortably for long periods.
Boasting streamlined, lightweight, stylish, intuitive designBoasting streamlined, lightweight, stylish, intuitive design
for optimum comfort and ease of use, the new systemsfor optimum comfort and ease of use, the new systemsoffer protection with the flexibility for changingoffer protection with the flexibility for changingenvironments, needs and comfort preferences. Theenvironments, needs and comfort preferences. Thelightweight and compact design aspect is of particularlightweight and compact design aspect is of particularimportance in this sector with its high proportion of femaleimportance in this sector with its high proportion of femaleworkers.workers.
The modular nature of the range allows it to be quicklyThe modular nature of the range allows it to be quicklyand easily adapted for changing work environments.and easily adapted for changing work environments.
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For example, if a hazard is introducedFor example, if a hazard is introduced
which cannot be filtered, a powered airwhich cannot be filtered, a powered air
system can even be changed over to asystem can even be changed over to a
supplied air system by replacing the turbosupplied air system by replacing the turbo
unit with a regulator. The downward facingunit with a regulator. The downward facing
air vent even allows staff to work sittingair vent even allows staff to work sitting
down if they prefer.down if they prefer.
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Among the new products being introduced is the 3 MAmong the new products being introduced is the 3 MVersaflo TRVersaflo TR--300 Powered Air Respirator ranges, which300 Powered Air Respirator ranges, whichcombines optimal comfort and performance. Thesecombines optimal comfort and performance. Theseproducts have an intelligent lithium battery which quicklyproducts have an intelligent lithium battery which quickly
charges, has no memory effect and incorporates a usefulcharges, has no memory effect and incorporates a usefulcharge indicator. They also have an audible and visualcharge indicator. They also have an audible and visualelectronic alarm that activates in case of low battery or lowelectronic alarm that activates in case of low battery or lowair flow. When combined with 3M Sair flow. When combined with 3M S--Series Hoods, 3MSeries Hoods, 3MVersaflo TRVersaflo TR--300and 3M Jupiter Powered Air Respirators300and 3M Jupiter Powered Air Respirators
offer the very highest protection factor demanded by thisoffer the very highest protection factor demanded by thissector.sector.
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Workers requiring supplied air can choose from aWorkers requiring supplied air can choose from arange of belt units, while all of the headtopsrange of belt units, while all of the headtopsfeature adjustable air flow, allowing the user tofeature adjustable air flow, allowing the user to
select whether they wish the air to flow over theirselect whether they wish the air to flow over theirface, head or visor. The range of headtopsface, head or visor. The range of headtopsavailable includes 3Ms Savailable includes 3Ms S--655 Premium Hood,655 Premium Hood,which was this year recognised in one of the mostwhich was this year recognised in one of the mostprestigious design competitions in the world,prestigious design competitions in the world,
receiving a red dot award for design from thereceiving a red dot award for design from theDesign Zentrum Nordrhein Westfalen.Design Zentrum Nordrhein Westfalen.
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Caroline Smith of 3Ms OccupationalCaroline Smith of 3Ms Occupational
Health & Environmental Safety groupHealth & Environmental Safety group
commented: 3M respiratory protectioncommented: 3M respiratory protection
products have always led the field inproducts have always led the field in
protection and performance and the newprotection and performance and the new
Versaflo Respiratory Protective SystemsVersaflo Respiratory Protective Systems
offer the same benefits alongside unrivalledoffer the same benefits alongside unrivalledcomfort, styling and ease of use.comfort, styling and ease of use.
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The versatility of the range means manyThe versatility of the range means many
applications can be safely catered for toapplications can be safely catered for to
meet legal requirements and usermeet legal requirements and user
preferences, and buyers can havepreferences, and buyers can have
confidence that they are purchasing highconfidence that they are purchasing high--
quality products from a proven and trustedquality products from a proven and trusted
manufacturer.manufacturer.
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Given the changing trends in the industry's globalGiven the changing trends in the industry's global
value chain and gradual shifts in internationalvalue chain and gradual shifts in international
trade patterns, if the former pioneers (US, UK,trade patterns, if the former pioneers (US, UK,
Switzerland, and Germany) wish to remainSwitzerland, and Germany) wish to remaincompetitive, they need to expand the developmentcompetitive, they need to expand the development
of new drugs. Otherwise, they will face aof new drugs. Otherwise, they will face a
continuing of the intensified competition fromcontinuing of the intensified competition from
developing nations that has appeared over the lastdeveloping nations that has appeared over the lastdecadedecade
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The political determinants that govern the pharmaceuticalThe political determinants that govern the pharmaceuticalindustry are all regulated by the Food and Drugindustry are all regulated by the Food and DrugAdministration. Their laws and guidelines rule allAdministration. Their laws and guidelines rule allproduction and manufacturing codes. The governmentproduction and manufacturing codes. The government
established this organization to protect the health andestablished this organization to protect the health andsafety of all customers by ensuring the quality of all drugssafety of all customers by ensuring the quality of all drugsproduced. As a result the regulations are extremely strictproduced. As a result the regulations are extremely strictand few drugs are actually passed and reach the openand few drugs are actually passed and reach the openmarket. Like the FDA, each nation has its own rules andmarket. Like the FDA, each nation has its own rules and
regulations, and American companies look for otherregulations, and American companies look for othernations to ensure stronger footholds.nations to ensure stronger footholds.
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Entering the field takes an immense amount ofEntering the field takes an immense amount ofcapital, due to the time needed to research, testcapital, due to the time needed to research, testand produce the drugs. Also drugs that haveand produce the drugs. Also drugs that havealready been created are protected under WTOalready been created are protected under WTO
patents. But, once a successful drug is marketed,patents. But, once a successful drug is marketed,the industry can be very lucrative. The demandthe industry can be very lucrative. The demandfor pharmaceuticals is relatively stable even iffor pharmaceuticals is relatively stable even ifother markets decrease in an economic slump, soother markets decrease in an economic slump, sowith constant research and production of newwith constant research and production of new
drugs, a company can benefit largelydrugs, a company can benefit largely
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This therefore would ensure globalThis therefore would ensure global
competitiveness and success for acompetitiveness and success for a
corporation; that is if the drugs also passedcorporation; that is if the drugs also passed
the other nations regulationsthe other nations regulations
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Over the past 50 years, the pharmaceuticalOver the past 50 years, the pharmaceutical
industry has experienced tremendous growth andindustry has experienced tremendous growth and
change. Along with this growth has come a serieschange. Along with this growth has come a series
of pressures to unite the industry underof pressures to unite the industry underinternational standards and regulations. Theseinternational standards and regulations. These
international regulatory guidelines have increasedinternational regulatory guidelines have increased
the barriers to entry in the international marketthe barriers to entry in the international market
and have driven top firms to create voluntaryand have driven top firms to create voluntarycorporate standards.corporate standards.
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