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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 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] |
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] |
Drug Safety
Term Given By Tushar Sharma (UPES Batch 2025) 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, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse ev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025) 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, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse ev ... [...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] |
Yellow Card Scheme
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. History The scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman. It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government. Scope Suspected adverse reactions are collected on all licensed medicines and vaccines, whether issued on prescription or bought over the counter from a pharmacist or supermarket. The scheme also includes all herbal preparations and unlicensed medicines. Adverse reactions can be reported by anyone; this is usually done by healthcare professionals ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and risks of drugs. Background Since 1978, responsibility for managing the WHO Programme for International Drug Monitoring has been carried by UMC. In the early years the staff consisted of just three pharmacists based at the Swedish Medical Products Agency (Läkemedelsverket); currently over 100 staff work in central Uppsala. The founding chairman and acting Director was Professor Åke Liljestrand. From 1990 to 2009 the Director was Professor Ralph Edwards. Since September 2009 Dr. Marie Lindquist is the Director. The Chief Medical Officer is Dr. Pia Caduff and the Head of Research is Dr. Niklas Norén. The work of the UMC is: * To co-ordinate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Society Of Pharmacovigilance
The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESOP), is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. Its official journal is ''Drug Safety''. See also *Uppsala Monitoring Centre (WHO) *Council for International Organizations of Medical Sciences *EudraVigilance *Society of Pharmacovigilance, India The Society of Pharmacovigilance, India (SoPI), is an Indian national non-profit scientific organisation, which aims at organizing training programmes and providing expertise in pharmacovigilance and enhance all aspects of the safe and proper use o ... References * External linksISOP Online International organisations based in London Pharmaceuticals policy {{pharmacy-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Association. The EEA links the EU member states and three EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same basic rules. These rules aim to enable 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. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. The EEA Treaty is a commercial treaty and differs from the EU Treaties in certain key respects. According to Article 1 its purpose is to "promote a continuous and balanced strengthening of trade and economic relati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly, birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are ... [...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] |
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Volumes EudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 - Pharmaceutical Legislation. **Volume 2 - Notice to Applicants. ***Volume 2A deals with procedures for marketing authorisation. ***Volume 2B deals with the presentation and content of the application dossier. ***Volume 2C deals with Guidelines. **Volume 3 - Guidelines. *Concerning Medicinal Products for human use in clinical trials (investigational medicinal products). **Volume 10 - Clinical trials. *Concerning Veterinary Medicinal Products: **Volume 5 - Pharmaceutical Legislation. **Volume 6 - Notice to Applicants. **Volume 7 - Guidelines. **Volume 8 - Maximum residue limits. *Concerning Medicinal Products for Human and Veterinary use: **Volume 4 - Good Manufacturing Practices. **Volume 9 - Pharmacovigilance. *Miscellaneous: **Guidelines on Good Distribution Practice of Medicinal ... [...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] |
