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75 relations: Amsterdam, Austria, Belgium, Brexit, Bulgaria, Centralisation, Committee for Medicinal Products for Human Use, Committee on Herbal Medicinal Products, Copenhagen, Croatia, Cyprus, Czech Republic, Decentralization, Denmark, Ethics committee (European Union), EudraCT, EudraGMP, EudraLex, EUDRANET, EudraPharm, EudraVigilance, European and Developing Countries Clinical Trials Partnership, European Banking Authority, European Commission, European Economic Area, European Federation of Pharmaceutical Industries and Associations, European Forum for Good Clinical Practice, European Free Trade Association, European Medicines Agency, European Parliament, European Union, Finland, Food and Drug Administration, Framework Programmes for Research and Technological Development, France, Gene therapy, Germany, Greece, Hungary, Iceland, Institute of Cancer Research, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Inverse benefit law, Ireland, Italy, Liechtenstein, London, Malta, Medication, Medicines and Healthcare products Regulatory Agency, ..., Milan, Netherlands, Norway, Orphan drug, Paediatric-use marketing authorisation, Paul Workman (scientist), Pharmacovigilance, Poland, Portugal, Protectionism, Qualified person (European Union), Regulation of therapeutic goods, Romania, Slovakia, Slovenia, Somatic cell, Sovereign state, Spain, Strasbourg, Supplementary protection certificate, Sweden, Tissue engineering, United Kingdom, Vytenis Andriukaitis, Westview Press. Expand index (25 more) »
Amsterdam
Amsterdam is the capital and most populous municipality of the Netherlands.
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Austria
Austria (Österreich), officially the Republic of Austria (Republik Österreich), is a federal republic and a landlocked country of over 8.8 million people in Central Europe.
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Belgium
Belgium, officially the Kingdom of Belgium, is a country in Western Europe bordered by France, the Netherlands, Germany and Luxembourg.
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Brexit
Brexit is the impending withdrawal of the United Kingdom (UK) from the European Union (EU).
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Bulgaria
Bulgaria (България, tr.), officially the Republic of Bulgaria (Република България, tr.), is a country in southeastern Europe.
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Centralisation
Centralisation (British), or centralization (both British and American), is the process by which the activities of an organization, particularly those regarding planning and decision-making, become concentrated within a particular location or group, keeping all of the important decision-making powers within the head office or the centre of the organisation.
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Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
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Committee on Herbal Medicinal Products
The Committee on Herbal Medicinal Products (HMPC), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on herbal medicines.
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Copenhagen
Copenhagen (København; Hafnia) is the capital and most populous city of Denmark.
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Croatia
Croatia (Hrvatska), officially the Republic of Croatia (Republika Hrvatska), is a country at the crossroads of Central and Southeast Europe, on the Adriatic Sea.
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Cyprus
Cyprus (Κύπρος; Kıbrıs), officially the Republic of Cyprus (Κυπριακή Δημοκρατία; Kıbrıs Cumhuriyeti), is an island country in the Eastern Mediterranean and the third largest and third most populous island in the Mediterranean.
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Czech Republic
The Czech Republic (Česká republika), also known by its short-form name Czechia (Česko), is a landlocked country in Central Europe bordered by Germany to the west, Austria to the south, Slovakia to the east and Poland to the northeast.
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Decentralization
Decentralization is the process by which the activities of an organization, particularly those regarding planning and decision-making, are distributed or delegated away from a central, authoritative location or group.
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Denmark
Denmark (Danmark), officially the Kingdom of Denmark,Kongeriget Danmark,.
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Ethics committee (European Union)
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.
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EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later.
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EudraGMP
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice.
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EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
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EUDRANET
EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications.
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EudraPharm
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) is the database of medicinal products authorised in the European Union, and includes the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling.
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EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).
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European and Developing Countries Clinical Trials Partnership
The European and Developing Countries Clinical Trials Partnership or EDCTP is a partnership between the European Union (EU), Norway, Switzerland and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccines against HIV/AIDS, tuberculosis, and malaria.
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European Banking Authority
The European Banking Authority (EBA) is a regulatory agency of the European Union headquartered in London.
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European Commission
The European Commission (EC) is an institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
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European Economic Area
The European Economic Area (EEA) is the area in which the Agreement on the EEA provides for the free movement of persons, goods, services and capital within the European Single Market, including the freedom to choose residence in any country within this area.
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European Federation of Pharmaceutical Industries and Associations
The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussels-based trade association founded in 1978 representing the research-based pharmaceutical industry operating in Europe.
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European Forum for Good Clinical Practice
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe.
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European Free Trade Association
The European Free Trade Association (EFTA) is a regional trade organization and free trade area consisting of four European states: Iceland, Liechtenstein, Norway, and Switzerland.
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European Medicines Agency
The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.
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European Parliament
The European Parliament (EP) is the directly elected parliamentary institution of the European Union (EU).
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European Union
The European Union (EU) is a political and economic union of EUnum member states that are located primarily in Europe.
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Finland
Finland (Suomi; Finland), officially the Republic of Finland is a country in Northern Europe bordering the Baltic Sea, Gulf of Bothnia, and Gulf of Finland, between Norway to the north, Sweden to the northwest, and Russia to the east.
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Food and Drug Administration
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
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Framework Programmes for Research and Technological Development
The Framework Programmes for Research and Technological Development, also called Framework Programmes or abbreviated FP1 to FP7 with "FP8" being named "Horizon 2020", are funding programmes created by the European Union/European Commission to support and foster research in the European Research Area (ERA).
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France
France, officially the French Republic (République française), is a sovereign state whose territory consists of metropolitan France in Western Europe, as well as several overseas regions and territories.
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Gene therapy
In the medicine field, gene therapy (also called human gene transfer) is the therapeutic delivery of nucleic acid into a patient's cells as a drug to treat disease.
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Germany
Germany (Deutschland), officially the Federal Republic of Germany (Bundesrepublik Deutschland), is a sovereign state in central-western Europe.
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Greece
No description.
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Hungary
Hungary (Magyarország) is a country in Central Europe that covers an area of in the Carpathian Basin, bordered by Slovakia to the north, Ukraine to the northeast, Austria to the northwest, Romania to the east, Serbia to the south, Croatia to the southwest, and Slovenia to the west.
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Iceland
Iceland is a Nordic island country in the North Atlantic, with a population of and an area of, making it the most sparsely populated country in Europe.
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Institute of Cancer Research
The Institute of Cancer Research (the ICR) is a public research institute and a constituent college of the University of London in London, United Kingdom, specialising in oncology.
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
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Inverse benefit law
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed.
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Ireland
Ireland (Éire; Ulster-Scots: Airlann) is an island in the North Atlantic.
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Italy
Italy (Italia), officially the Italian Republic (Repubblica Italiana), is a sovereign state in Europe.
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Liechtenstein
Liechtenstein, officially the Principality of Liechtenstein (Fürstentum Liechtenstein), is a doubly landlocked German-speaking microstate in Central Europe.
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London
London is the capital and most populous city of England and the United Kingdom.
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Malta
Malta, officially known as the Republic of Malta (Repubblika ta' Malta), is a Southern European island country consisting of an archipelago in the Mediterranean Sea.
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Medication
A medication (also referred to as medicine, pharmaceutical drug, or simply drug) is a drug used to diagnose, cure, treat, or prevent disease.
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Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
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Milan
Milan (Milano; Milan) is a city in northern Italy, capital of Lombardy, and the second-most populous city in Italy after Rome, with the city proper having a population of 1,380,873 while its province-level municipality has a population of 3,235,000.
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Netherlands
The Netherlands (Nederland), often referred to as Holland, is a country located mostly in Western Europe with a population of seventeen million.
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Norway
Norway (Norwegian: (Bokmål) or (Nynorsk); Norga), officially the Kingdom of Norway, is a unitary sovereign state whose territory comprises the western portion of the Scandinavian Peninsula plus the remote island of Jan Mayen and the archipelago of Svalbard.
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Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.
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Paediatric-use marketing authorisation
Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years.
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Paul Workman (scientist)
Paul Workman, (born 30 March 1952) is a British scientist noted for his work on the discovery and development of pharmaceutical agents in the field of oncology.
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Pharmacovigilance
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
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Poland
Poland (Polska), officially the Republic of Poland (Rzeczpospolita Polska), is a country located in Central Europe.
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Portugal
Portugal, officially the Portuguese Republic (República Portuguesa),In recognized minority languages of Portugal: Portugal is the oldest state in the Iberian Peninsula and one of the oldest in Europe, its territory having been continuously settled, invaded and fought over since prehistoric times.
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Protectionism
Protectionism is the economic policy of restricting imports from other countries through methods such as tariffs on imported goods, import quotas, and a variety of other government regulations.
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Qualified person (European Union)
Qualified person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use).
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Regulation of therapeutic goods
The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction.
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Romania
Romania (România) is a sovereign state located at the crossroads of Central, Eastern, and Southeastern Europe.
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Slovakia
Slovakia (Slovensko), officially the Slovak Republic (Slovenská republika), is a landlocked country in Central Europe.
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Slovenia
Slovenia (Slovenija), officially the Republic of Slovenia (Slovene:, abbr.: RS), is a country in southern Central Europe, located at the crossroads of main European cultural and trade routes.
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Somatic cell
A somatic cell (from the Greek σῶμα sôma, meaning "body") or vegetal cell is any biological cell forming the body of an organism; that is, in a multicellular organism, any cell other than a gamete, germ cell, gametocyte or undifferentiated stem cell.
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Sovereign state
A sovereign state is, in international law, a nonphysical juridical entity that is represented by one centralized government that has sovereignty over a geographic area.
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Spain
Spain (España), officially the Kingdom of Spain (Reino de España), is a sovereign state mostly located on the Iberian Peninsula in Europe.
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Strasbourg
Strasbourg (Alsatian: Strossburi; Straßburg) is the capital and largest city of the Grand Est region of France and is the official seat of the European Parliament.
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Supplementary protection certificate
In the European Economic Area (European Union member countries, Iceland, Liechtenstein and Norway), a supplementary protection certificate (SPC) is a sui generis intellectual property (IP) right that extends the duration of certain rights associated with a patent.
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Sweden
Sweden (Sverige), officially the Kingdom of Sweden (Swedish), is a Scandinavian country in Northern Europe.
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Tissue engineering
Tissue engineering is the use of a combination of cells, engineering and materials methods, and suitable biochemical and physicochemical factors to improve or replace biological tissues.
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United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain,Usage is mixed with some organisations, including the and preferring to use Britain as shorthand for Great Britain is a sovereign country in western Europe.
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Vytenis Andriukaitis
Vytenis Povilas Andriukaitis (born 9 August 1951) is Lithuania's European Commissioner, a heart surgeon, and a co-signatory to the 1990 Act of the Re-Establishment of the State of Lithuania.
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Westview Press
Westview Press was an American publishing house.
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Redirects here:
Committee on Orphan Medicinal Products, European Agency for the Evaluation of Medicine, European Medicines Evaluation Agency.
References
[1] https://en.wikipedia.org/wiki/European_Medicines_Agency
