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Pharmacovigilance(PVor PhV), also known as Drug Safety, is

thepharmacologicalsciencerelating to the collection, detection, assessment, monitoring, and

prevention of adverse effectswith pharmaceutical products. The etymologicalroots for the word

"pharmacovigilance" are: pharmakon(Greek for drug) and vigilare(Latin for to keep watch). s such,pharmacovigilance heavily focuses on adverse drug reactions, or !s, which are defined as any

response to a drug which is no#ious and unintended, including lack of efficacy. (The condition, that

this definition only applies with the doses normally used for the prophyla#is, diagnosis or therapy of

disease, or for the modification of physiological disorder function was e#cluded with the latest

amendment of the applica$le legislation.) %edication errorssuch as overdose, and misuse and

a$use of a drug as well as drug e#posure during pregnancy and $reastfeeding, are also of interest

(even without adverse event itself), $ecause they may result in an !.

&nformation received from patients and healthcare providers via pharmacovigilance agreements

('s), as well as other sources such as themedical literature,plays a critical role in providing the

data necessary for pharmacovigilance to take place. &n fact, in order to market or to test a

pharmaceutical product in most countries, adverse event data received $y the license holder (usually

a pharmaceutical company) must $e su$mitted to the local drug regulatory authority. (ee dverse

*vent eporting $elow.)

+ltimately, pharmacovigilance is concerned with identifying the haards associated with

pharmaceutical products and with minimiing the risk of any harm that may come to patients.

Clinical Research data managementis the e#pert application of informatics theories and methods

to the definition, collection and processing of data for clinical studies and the design of associated

work and data flow. -linical esearch !ata %anagement assures collection, integration and

availa$ility of data at appropriate uality and cost. -linical esearch !ata %anagement supports the

conduct, management and analysis of studies across the spectrum of clinical research as defined $y

the /ational &nstitutes of 0ealth (/&0). The ultimate goal of -!% is to assure that data support

conclusions drawn from research. chieving this goal protects pu$lic health and confidence in

marketed therapeutics.

regulatory agency(also regulatory authority, regulatory bodyor regulator) is apu$lic

authorityorgovernment agencyresponsi$le for e#ercising autonomous authority over some area of

human activity in a regulatoryor supervisorycapacity. n independent regulatory agencyis a

regulatory agency that is independent from other $ranches or arms of the government.

http://en.wikipedia.org/wiki/Pharmacologyhttp://en.wikipedia.org/wiki/Pharmacologyhttp://en.wikipedia.org/wiki/Sciencehttp://en.wikipedia.org/wiki/Adverse_effect_(medicine)http://en.wikipedia.org/wiki/Pharmaceutical_drughttp://en.wikipedia.org/wiki/Etymologicalhttp://en.wikipedia.org/wiki/Adverse_drug_reactionhttp://en.wikipedia.org/wiki/Medication_errorhttp://en.wikipedia.org/wiki/Medical_literaturehttp://en.wikipedia.org/wiki/Medical_literaturehttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/Regulationhttp://en.wikipedia.org/wiki/Supervisorhttp://en.wikipedia.org/wiki/Sciencehttp://en.wikipedia.org/wiki/Adverse_effect_(medicine)http://en.wikipedia.org/wiki/Pharmaceutical_drughttp://en.wikipedia.org/wiki/Etymologicalhttp://en.wikipedia.org/wiki/Adverse_drug_reactionhttp://en.wikipedia.org/wiki/Medication_errorhttp://en.wikipedia.org/wiki/Medical_literaturehttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Public_benefit_corporationhttp://en.wikipedia.org/wiki/Government_agencyhttp://en.wikipedia.org/wiki/Regulationhttp://en.wikipedia.org/wiki/Supervisorhttp://en.wikipedia.org/wiki/Pharmacology

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Rank Company CountryTotal

Revenues(USDbillions)

Total

Revenues(reportedcurrency in millions

ofUSD)

Change

2!2 (")

#et income$

(loss)(reportedcurrency in

millions)

Ch

2!

4 $#a%oSith'#ine[7]United

'in(do45.4 45402 1.0 8015

5 *o+artis[] S"itzer#and 5720 4.0 22

6 Sanofi[11] -ran!e 44.6[12] 44563 6.5 043

7 stra/ene!a[13] U'S"eden 25.7[14] 25711 )6.0 830

8ott

aoratories [15]United States 21.8[16] 21848 4.0 2576

er! & o.[17] United States 44.0[18] 44000 )7.0 4404

10 aer ea#thare [1] $eran 54.2[20] 54211 1.0 4702

11 9#i i##[21] United States 23.1[22] 23113 2.0 4684

12 risto#)ers

S:;i [23]United States 16.4[24] 16385 7.0 2340

http://en.wikipedia.org/wiki/GlaxoSmithKlinehttp://en.wikipedia.org/wiki/GlaxoSmithKlinehttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-7http://en.wikipedia.org/wiki/Novartishttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-9http://en.wikipedia.org/wiki/Sanofihttp://en.wikipedia.org/wiki/Sanofihttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-11http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-12http://en.wikipedia.org/wiki/AstraZenecahttp://en.wikipedia.org/wiki/AstraZenecahttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-13http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-14http://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-15http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-16http://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-17http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-18http://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-19http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-20http://en.wikipedia.org/wiki/Eli_Lilly_and_Companyhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-21http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-22http://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-23http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-24http://en.wikipedia.org/wiki/GlaxoSmithKlinehttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-7http://en.wikipedia.org/wiki/Novartishttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-9http://en.wikipedia.org/wiki/Sanofihttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-11http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-12http://en.wikipedia.org/wiki/AstraZenecahttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-13http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-14http://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-15http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-16http://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-17http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-18http://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-19http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-20http://en.wikipedia.org/wiki/Eli_Lilly_and_Companyhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-21http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-22http://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-23http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies#cite_note-24

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Rank Company CountryTotal

Revenues(USDbillions)

Total

Revenues(reportedcurrency in millions

ofUSD)

Change

2!2 (")

#et income$

(loss)(reportedcurrency in

millions)

Ch

2!