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DARWIN EU
The Data Analysis and Real World Interrogation Network (DARWIN EU) is a European Union (EU) initiative coordinated by the European Medicines Agency (EMA) to generate and utilize real world evidence (RWE) to support the evaluation and supervision of medicines across the EU. The project aims to enhance decision-making in regulatory processes by drawing on anonymized data from routine healthcare settings. Overview DARWIN EU was officially launched in 2022 as part of the EMA's broader strategy to harness big data for public health benefits. The network facilitates access to real-world data from a wide array of sources, including Electronic health records, Disease registries, hospital databases, and Biobanks. These data are standardized using the OMOP (Observational Medical Outcomes Partnership) common data model to ensure interoperability and comparability across datasets. Objectives The key goals of DARWIN EU include: * Supporting the EMA and national regulatory agencies in cond ...
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European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ...
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Netherlands
, Terminology of the Low Countries, informally Holland, is a country in Northwestern Europe, with Caribbean Netherlands, overseas territories in the Caribbean. It is the largest of the four constituent countries of the Kingdom of the Netherlands. The Netherlands consists of Provinces of the Netherlands, twelve provinces; it borders Germany to the east and Belgium to the south, with a North Sea coastline to the north and west. It shares Maritime boundary, maritime borders with the United Kingdom, Germany, and Belgium. The official language is Dutch language, Dutch, with West Frisian language, West Frisian as a secondary official language in the province of Friesland. Dutch, English_language, English, and Papiamento are official in the Caribbean Netherlands, Caribbean territories. The people who are from the Netherlands is often referred to as Dutch people, Dutch Ethnicity, Ethnicity group, not to be confused by the language. ''Netherlands'' literally means "lower countries" i ...
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Artificial Intelligence By Year
Artificiality (the state of being artificial, anthropogenic, or man-made) is the state of being the product of intentional human manufacture, rather than occurring naturally through processes not involving or requiring human activity. Connotations Artificiality often carries with it the implication of being false, counterfeit, or deceptive. The philosopher Aristotle wrote in his ''Rhetoric'': However, artificiality does not necessarily have a negative connotation, as it may also reflect the ability of humans to replicate forms or functions arising in nature, as with an artificial heart or artificial intelligence. Political scientist and artificial intelligence expert Herbert A. Simon observes that "some artificial things are imitations of things in nature, and the imitation may use either the same basic materials as those in the natural object or quite different materials.Herbert A. Simon, ''The Sciences of the Artificial'' (1996), p. 4. Simon distinguishes between the artific ...
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Medical Statistics
Medical statistics (also health statistics) deals with applications of statistics to medicine and the health sciences, including epidemiology, public health, forensic medicine, and clinical research. Medical statistics has been a recognized branch of statistics in the United Kingdom for more than 40 years, but the term has not come into general use in North America, where the wider term 'biostatistics' is more commonly used.Dodge, Y. (2003) ''The Oxford Dictionary of Statistical Terms'', OUP. However, "biostatistics" more commonly connotes all applications of statistics to biology. Medical statistics is a subdiscipline of statistics. It is the science of summarizing, collecting, presenting and interpreting data in medical practice, and using them to estimate the magnitude of associations and test hypotheses. It has a central role in medical investigations. It not only provides a way of organizing information on a wider and more formal basis than relying on the exchange of anecdot ...
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Big Data Products
Big or BIG may refer to: * Big, of great size or degree Film and television * ''Big'' (film), a 1988 fantasy-comedy film starring Tom Hanks * ''Big'', a 2023 Taiwanese children's film starring Van Fan and Chie Tanaka * '' Big!'', a Discovery Channel television show * ''Richard Hammond's Big'', a television show presented by Richard Hammond * ''Big'' (TV series), a 2012 South Korean TV series * "Big" (''My Hero''), a 2003 television episode * '' Banana Island Ghost'', a 2017 fantasy action comedy film Music * '' Big: the musical'', a 1996 musical based on the film * Big Records, a record label * ''Big!'' (Betty Who album) * ''Big'' (album), a 2007 album by Macy Gray * "Big" (Brassmunk song) * "Big" (Dead Letter Circus song) * "Big" (Fontaines D.C. song) * "Big" (Juice Wrld song) * "Big" (Sneaky Sound System song) * "Big" (Rita Ora and Imanbek song) * "Big" (Young M.A song) * "Big", a 1990 song by New Fast Automatic Daffodils * "Big", a 2021 song by Jade Eagleson f ...
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Real World Evidence
Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective observational studies. In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence. Real-world evidence comes into play when clinical trials cannot really account for the entire patient population of a particular disease. Patients with comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment in question as expected. RWE provides answers to these problems and also analyzes the effects of drugs over a longer period of time. Pharmaceutical companies and health insurance payers study RWE t ...
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Pandemic Preparedness And Response Act
The Pandemic Preparedness and Response Act is a bill introduced on October 5, 2005, by U.S. Senators Harry Reid, Evan Bayh, Dick Durbin, Ted Kennedy, Barack Obama, and Tom Harkin in response to the growing threat of an outbreak of avian influenza. The bill calls for: * Preparing for a pandemic by finalizing, implementing and funding pandemic preparedness and response plans. * Improving surveillance and international partnerships to monitor the spread of avian flu and detect the emergence of a flu strain with pandemic potential immediately. * Protecting Americans through the development, production and distribution of an effective vaccine. * Planning ahead for a pandemic by stockpiling antivirals, vaccines and other essential medications and supplies. * Strengthening the public health infrastructure. * Increasing awareness and education about pandemic flu. * Devoting adequate resources to pandemic preparedness. "This bill never became law. This bill was proposed in a previous sessio ...
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Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or, especially in the case of device, for the modification of physiological disorder function. In 2010, the European Union expanded PV to include medication errors such as overdose, misuse, and abuse of a drug as well as drug exposure during pregnancy and breastfeeding. These are monitored even in the absence of an adverse event, because they may result in an adve ...
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Pilot Fatigue
The International Civil Aviation Organization (ICAO) defines fatigue as "A physiological state of reduced mental or physical performance capability resulting from sleep loss or extended wakefulness, circadian phase, or workload." The phenomenon places great risk on the crew and passengers of an airplane because it significantly increases the chance of pilot error. Fatigue is particularly prevalent among pilots because of "unpredictable work hours, long duty periods, circadian disruption, and insufficient sleep". These factors can occur together to produce a combination of sleep deprivation, circadian rhythm effects, and 'time-on task' fatigue. Regulators attempt to mitigate fatigue by limiting the number of hours pilots are allowed to fly over varying periods of time. Effect on flight safety It has been estimated that 4-7% of civil aviation incidents and accidents can be attributed to fatigued pilots. "In the last 16 years, fatigue has been associated with 250 fatalities in ai ...
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Brno
Brno ( , ; ) is a Statutory city (Czech Republic), city in the South Moravian Region of the Czech Republic. Located at the confluence of the Svitava (river), Svitava and Svratka (river), Svratka rivers, Brno has about 403,000 inhabitants, making it the second-largest city in the Czech Republic after the capital, Prague, and one of the List of cities in the European Union by population within city limits, 100 largest cities of the European Union. The Brno metropolitan area has approximately 730,000 inhabitants. Brno is the former capital city of Moravia and the political and cultural hub of the South Moravian Region. It is the centre of the Judiciary of the Czech Republic, Czech judiciary, with the seats of the Constitutional Court of the Czech Republic, Constitutional Court, the Supreme Court of the Czech Republic, Supreme Court, the Supreme Administrative Court of the Czech Republic, Supreme Administrative Court, and the Supreme Public Prosecutor's Office, and a number of state ...
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Rotterdam
Rotterdam ( , ; ; ) is the second-largest List of cities in the Netherlands by province, city in the Netherlands after the national capital of Amsterdam. It is in the Provinces of the Netherlands, province of South Holland, part of the North Sea mouth of the Rhine–Meuse–Scheldt delta, via the Nieuwe Maas, New Meuse inland shipping channel, dug to connect to the Meuse at first and now to the Rhine. Rotterdam's history goes back to 1270, when a dam was constructed in the Rotte (river), Rotte. In 1340, Rotterdam was granted city rights by William II, Count of Hainaut, William IV, Count of Holland. The Rotterdam–The Hague metropolitan area, with a population of approximately 2.7 million, is the List of urban areas in the European Union, 10th-largest in the European Union and the most populous in the country. A major logistic and economic centre, Rotterdam is Port of Rotterdam, Europe's largest seaport. In 2022, Rotterdam had a population of 655,468 and is home to over 1 ...
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