European Medicines AgencyThe European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies.
Good clinical practiceGood clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software.
EuropeEurope is a continent comprising the westernmost peninsulas of Eurasia, located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It shares the continental landmass of Afro-Eurasia with both Africa and Asia. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east. Europe is commonly considered to be separated from Asia by the watershed of the Ural Mountains, the Ural River, the Caspian Sea, the Greater Caucasus, the Black Sea and the waterways of the Turkish Straits.
Languages of EuropeMost languages of Europe belong to the Indo-European language family. Out of a total European population of 744 million as of 2018, some 94% are native speakers of an Indo-European language. Within Indo-European, the three largest phyla in Europe are Romance, Germanic, and Slavic; they have more than 200 million speakers each and together account for close to 90% of Europeans.
European FederationThe European Federation, also referred to as the United States of Europe (USE), European State, or Federal Europe, is the hypothetical scenario of European integration leading to the formation of a sovereign superstate (similar to the United States of America), organised as a federation of the member countries of the European Union (EU), as contemplated by political scientists, politicians, geographers, historians, futurologists and fiction writers.
Quality (business)In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something (goods or services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace.
Europe DayEurope Day is a day celebrating "peace and unity in Europe" celebrated on 5 May by the Council of Europe and on 9 May by the European Union. The first recognition of Europe Day was by the Council of Europe, introduced in 1964. The European Union later started to celebrate its own European Day in commemoration of the 1950 Schuman Declaration which first proposed the European Coal and Steel Community, leading it to be referred to by some as "Schuman Day" or "Day of the united Europe".
Eastern EuropeEastern Europe is a subregion of the European continent. As a largely ambiguous term, it has a wide range of geopolitical, geographical, ethnic, cultural, and socio-economic connotations. The region stretches from the Ural Mountains in the east to the borders of Poland and Romania. Most definitions include the countries of Belarus, Russia, and Ukraine while less restrictive definitions also include Bulgaria, the Czech Republic, Hungary, Moldova, Poland, Romania, and Slovakia.
Council of EuropeThe Council of Europe (CoE; Conseil de l'Europe, CdE) is an international organisation established in the wake of World War II to uphold human rights, democracy and the rule of law in Europe. Founded in 1949, it brings together 46 member states, with a population of approximately 675 million; it operates with an annual budget of approximately 500 million euros. The organisation is distinct from the European Union (EU), although people sometimes confuse the two organisations - partly because the EU has adopted the original European flag, designed for the Council of Europe in 1955, as well as the European anthem.
Quality managementQuality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management.
Quality assuranceQuality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design.
