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 Trans European Services for Telematics between Administrations ( TESTA) system is the private IP-based network of the European Community.
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. Pharmacovigilance (PV is the pharmacological Science relating to the detection assessment understanding and prevention of adverse effects, particularly
See also
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eHealth (also written e-health) is a relatively recent term for healthcare practice which is supported by electronic processes and communication The European Medicines Agency ( EMEA) is a European agency for the evaluation of medicinal products. EudraCT ( E uropean U nion D rug R egulating A uthorities C linical T rials is the European Clinical Trials Database EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. EudraPharm ( E uropean U nion D rug R egulating A uthorities Pharm aceutical Database is the database of medicinal products authorised EudraVigilance ( E uropean U nion D rug R egulating A uthorities Pharmaco' vigilance') is the European data processing network Qualified Person ( QP) is a technical term used in European Union Pharmaceutical regulation ( Directive 2001/83/EC for Medicinal products for human use The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in The European Union ( EU) is a political and economic union of twenty-seven member states, located primarily in
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