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BfArM
The Federal Institute for Drugs and Medical Devices (in German language, German: Bundesinstitut für Arzneimittel und Medizinprodukte – ''BfArM'') is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (Germany), Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. Its president is Karl Broich. Portfolio The Federal Institute for Drugs and Medical Devices is one of the two independent federal higher authorities in the German health care sector alongside the ''Paul-Ehrlich-Institut'' (PEI) under the Federal Ministry of Health (Germany), Federal Ministry of Health. It is headquartered in Bonn, Germany. The core tasks of the BfArM as a Regulatory agency, regulatory authority include the approval and registration of Medical device, medical devices and Medication, products, including drugs in the special therapeutic areas of herbalism and Paraherbalism, paraherbals, as well as the identification, assessment and defence agai ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
German Institute For Medical Documentation And Information
The German Institute for Medical Documentation and Information (), abbreviated DIMDI, was a German organization responsible for medical information classification and management. It was a government Institute of the German Federal Ministry of Health and was located in Cologne, Germany Germany, officially the Federal Republic of Germany, is a country in Central Europe. It lies between the Baltic Sea and the North Sea to the north and the Alps to the south. Its sixteen States of Germany, constituent states have a total popu .... The DIMDI published official medical classifications such as ICD-10-GM and OPS (German Procedure Classification) and maintained medical terminology dictionaries, thesauri, nomenclatures and catalogs (e.g. MeSH, UMDNS, Alpha-ID, LOINC, OID) that are important for health information exchange and other applications. DIMDI also developed and operated database-supported information systems for drugs and medical devices and was responsible for a program of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Ministry Of Health (Germany)
The Federal Ministry of Health (, ; abbreviated BMG) is a cabinet-level ministry of the Federal Republic of Germany. It is the highest German federal government department responsible for health. The ministry is officially located in Bonn and with a second office, which houses the ministry's management, located in Berlin. History The Federal Ministry of Health was founded in 1961; in 1969 it was merged with the Federal Ministry for Family and Youth to create the new Federal Ministry for Youth, Family and Health. In 1991, the Federal Ministry of Health was restored. In 2002, it was expanded to include social affairs and renamed "Federal Ministry of Health and Social Security" ('). It was headed by the Federal Minister for Health and Social Security. Its portfolio included one part of the former Federal Ministry of Labour and the Social Order. The other part of the latter was added to the portfolio of the newly created Federal Ministry for Economics and Labour. Under the gr ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Government Of Germany
The Federal Government (, ; abbr. BReg) is the chief Executive (government), executive body of the Germany, Federal Republic of Germany and exercises executive power at the Federal level (Germany), federal level. It consists of the Chancellor of Germany, Federal Chancellor and the Federal Minister (government), Ministers. The fundamentals of the government's organisation, as well as the method of its election and appointment, along with the procedure for its dismissal, are set down in thsixth section(articles 62 to 69) of the Basic Law for the Federal Republic of Germany, German Basic Law (''Grundgesetz''). The Chancellor and the other members of the government are allowed to be also members of the ''Bundestag'' (though they are not required to be). An extended body is the Federal Cabinet (''Bundeskabinett)'', which includes the Federal Government (consisting of the Federal Chancellor and Federal Ministers), the Heads of the German Chancellery, Head of the Federal Chancellery ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Risk
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication. Classific ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé
Agence nationale de sécurité du médicament et des produits de santé (ANSM) is a drug regulator in France. ANSM is responsible for assessing the benefits and risks associated with the use of drugs and other medical products throughout their life-cycle: it assesses the safety, efficacy and quality of these products and must balance patient safety with access to novel therapies. Agence française de sécurité sanitaire des produits de santé (AFSSAPS) ANSM superseded the tasks and duties of Agence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products) on 1 May 2012. AFSSAPS (or AFSSaPS) was a French government The Government of France (, ), officially the Government of the French Republic (, ), exercises Executive (government), executive power in France. It is composed of the Prime Minister of France, prime minister, who is the head of government, ... agency whose main mission was to assess health risks posed by health ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Telematics
Telematics is an interdisciplinary field encompassing telecommunications, vehicular technologies (road transport, road safety, etc.), electrical engineering (sensors, instrumentation, wireless communications, etc.), and computer science (multimedia, Internet, etc.). Telematics can involve any of the following: * The technology of sending, receiving, and storing information using telecommunication devices to control remote objects * The integrated use of telecommunications and informatics for application in vehicles and to control vehicles on the move * Global navigation satellite system technology integrated with computers and mobile communications technology in automotive navigation systems * (Most narrowly) The use of such systems within road vehicles (also called vehicle telematics) History Telematics is a translation of the French word ''télématique,'' which was first coined by Simon Nora and Alain Minc in a 1978 report to the French government on the computerizati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ECTD
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). History Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, and version 3.0 was finalized on October 8 of the same year. , the most current version is 3.2.2, released on July 16, 2008. A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that mi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Berlin-Bonn Act
The Berlin/Bonn Act () regulated the move of the Bundestag and parts of the government of Germany from Bonn to Berlin. It also regulated the move of certain Federal agencies and other German federal facilities to Bonn. The act was a consequence of the '' Hauptstadtbeschluss'' () of 20 June 1991, which made Berlin the seat of government. Berlin had already been the capital of the united Germany since the Unification Treaty of 3 October 1990. The Berlin/Bonn Act was enacted on 26 April 1994. The act's full official title is ''Act for the implementation of the enactment of the German Bundestag of 20 June 1991 for the completion of the German unity'' (). The Berlin/Bonn act determined which federal ministries moved to the capital and gave the city certain commitments regarding the preservation of Bonn as a location of politics. In addition, it awarded the city the unique title of the Federal City. The act was implemented incrementally. The most important year was 1999, when the Bu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Berlin
Berlin ( ; ) is the Capital of Germany, capital and largest city of Germany, by both area and List of cities in Germany by population, population. With 3.7 million inhabitants, it has the List of cities in the European Union by population within city limits, highest population within its city limits of any city in the European Union. The city is also one of the states of Germany, being the List of German states by area, third smallest state in the country by area. Berlin is surrounded by the state of Brandenburg, and Brandenburg's capital Potsdam is nearby. The urban area of Berlin has a population of over 4.6 million and is therefore the most populous urban area in Germany. The Berlin/Brandenburg Metropolitan Region, Berlin-Brandenburg capital region has around 6.2 million inhabitants and is Germany's second-largest metropolitan region after the Rhine-Ruhr region, as well as the List of EU metropolitan areas by GDP, fifth-biggest metropolitan region by GDP in the European Union. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Health Agency
The Federal Health Agency () was a federal government agency and the central research institution for public health in Germany. It was founded in 1876, named the Imperial Health Agency (). It was succeeded by the Reichsgesundheitsamt in 1918 and by the Bundesgesundheitsamt in 1952 (both meaning Federal Health Agency). The agency was dissolved in 1994, and its responsibilities transferred to three institutions, the Federal Institute for Drugs and Medical Devices, the Robert Koch Institute The Robert Koch Institute (RKI) is a German federal government agency and research institute responsible for disease control and prevention. It is located in Berlin and Wernigerode. As an upper federal agency, it is subordinate to the Federa ... and the Federal Institute for Health Consumer Protection and Veterinary Medicine.Hans-Joachim Weise, ''Bundesgesundheitsamt – BGA; 100 Jahre Forschung für die Gesundheit'', 1976 References German federal agencies Government health agencies o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
