EUDRANET
Encyclopedia
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:
Trans European Services for Telematics between Administrations
The Trans European Services for Telematics between Administrations system is the private IP-based network of the European Union. TESTA is a telecommunications interconnection platform for secure information exchange between the European public administrations.TESTA is not a single network, but a...
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 pharmacovigilancePharmacovigilancePharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
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
- eHealthEHealtheHealth is a relatively recent term for healthcare practice supported by electronic processes and communication, dating back to at least 1999...
- EudraCTEudraCTEudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards...
- EudraGMPEudraGMPEudraGMP 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...
- EudraPharmEudraPharmEudraPharm is the database of medicinal products authorised in the European Union, and includes the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- Qualified PersonQualified PersonQualified Person is a technical term used in European Union pharmaceutical regulation...
External links
- EUDRANET
- Projects of Common Interest for Administrations (European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
) - e-Health (European UnionEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
)