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EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials registry, 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. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials (e.g. Serious adverse event, SUSAR reports). Public Side The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own loc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). 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. The hope was that this plan would not onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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. The aim of EUDRANET is to provide appropriate secure services for inter-Administration data interchange and for exchanges between Administrations and industry. EUDRANET is based on the TESTA backbone infrastructure provided by the IDA Programme. The processes which EUDRANET supports include: * The submission and evaluation of marketing authorisation applications by pharmaceutical companies; * The pharmacovigilance of products on the market to ensure the maintenance of high standards of quality as well as adhering to European national and regional regulations; * The dissemination of relevant information to industry, scientific experts and regulators. See also * eHealth * EudraCT * EudraGMP * EudraPharm * EudraVi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraGMP
EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general public, via Internet, is available since 2009 using the URL : http://eudragmp.ema.europa.eu. EudraGMP is part of the EU telematics strategy, which has been conceived in order to meet the strategic objectives of the European Commission, the European Medicines Agency and the Member State competent authorities. EudraGMP is part of a larger database known as EudraGMDP, which contains information on: * “Manufacturing and import authorisations * Good manufacturing Practice (GMP) certificates * Statements of non-compliance with GMP * GMP inspection planning in third countries” The public database allows the general public access to information regarding manufacturing inspections completed by regulatory authorities from all European Economi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EudraPharm
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling. The EudraPharm database was accessible to the general public and the information thus made available was worded in an appropriate and comprehensible manner. It was decommissioned in 2019. The EudraPharm database of authorised medicinal products was foreseen in thEU Regulation 726/2004 EudraPharm contained only details of products that were licensed using the Centralised procedure. Therefore, for human medicines, it was only a new interface for information that was available via the EPARs section at the EMEA. See also * European Medicines Agency * EUDRANET * EudraCT * EudraGMP * EudraVigilance EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. The European EudraVigilance system deals with the: * Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2B specifications): ** EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions ( SUSARs). ** EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs. * Early detection of possible safety signals from marketed drugs for human use.CIOMS Working Group VIII. Practical aspects of signal detection in pharmacovigilance. Geneva: Council for International Organiz ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials Registry
Preregistration is the practice of registering the hypotheses, methods, and/or analyses of a scientific study before it is conducted. This can include analyzing primary data or secondary data. Clinical trial registration is similar, although it may not require the registration of a study's analysis protocol. Finally, registered reports include the peer review and in principle acceptance of a study protocol prior to data collection. Preregistration assists in the identification and/or reduction of a variety of potentially problematic research practices, including p-hacking, publication bias, data dredging, inappropriate forms of post hoc analysis, and (relatedly) HARKing. It has recently gained prominence in the open science community as a potential solution to some of the issues that are thought to underlie the replication crisis. However, critics have argued that it may not be necessary when other open science practices are implemented such as Registered Reports. Types Standa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a '' sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to act ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directive 2001/20/EC
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Serious Adverse Event
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose #Results in death #Is life-threatening #Requires inpatient hospitalization or causes prolongation of existing hospitalization #Results in persistent or significant disability/incapacity #May have caused a congenital anomaly/birth defect #Requires intervention to prevent permanent impairment or damage The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.” Research Investigators in human clinical trials are obligated to report these events in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Agencia Española De Medicamentos Y Productos Sanitarios
The Spanish Agency of Medicines and Medical Devices ( es, Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products. The agency is responsible for the regulation and authorization of clinical trials and the commercialization of sanitary products for human use, the planification and evaluation of those products along with the European Medicines Agency (EMA); the authorization of clinical laboratories, develop the specific rules to ensure the quality of the medical products and inspect all sanitary products of the central government competence. Since 1998, the agency has powers over the control, evaluation and authorization of animal health products. The agency was created under the name of ''Agencia Española del Medicamento'' by the Fiscal, Administrative a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Clinical Research
European, or Europeans, or Europeneans, may refer to: In general * ''European'', an adjective referring to something of, from, or related to Europe ** Ethnic groups in Europe ** Demographics of Europe ** European cuisine, the cuisines of Europe and other Western countries * ''European'', an adjective referring to something of, from, or related to the European Union ** Citizenship of the European Union ** Demographics of the European Union In publishing * ''The European'' (1953 magazine), a far-right cultural and political magazine published 1953–1959 * ''The European'' (newspaper), a British weekly newspaper published 1990–1998 * ''The European'' (2009 magazine), a German magazine first published in September 2009 *''The European Magazine'', a magazine published in London 1782–1826 *''The New European'', a British weekly pop-up newspaper first published in July 2016 Other uses * * Europeans (band), a British post-punk group, from Bristol See also * * * Europe (disambi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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