EudraVigilance — (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and also for following… … Wikipedia
Pharmacovigilance — Contents 1 Risks of medical treatment 2 Finding the risks of drugs 3 Spontaneous reporting … Wikipedia
European Medicines Agency — European Medicines Agency … Wikipedia
Pharmakovigilanz — Die Pharmakovigilanz (v. griech. φάρμακον, pharmacon, Heilmittel, Gift, Zaubermittel; lat. vigilantia „Wachheit“, „Schlauheit“) bedeutet die laufende und systematische Überwachung der Sicherheit eines Fertigarzneimittels für Mensch oder Tier mit… … Deutsch Wikipedia
Lesebestätigung — Eine Message Disposition Notification (MDN) ist eine Bestätigung des Erhalts einer Botschaft an dessen Versender. Die Übertragung von MDNs kann über E Mail, Datenaustausch übers Internet oder über FTP Standards erfolgen. Bei E Mails spricht man… … Deutsch Wikipedia
EU-Pharmapaket — Das EU Pharmapaket (auch: Pharmapaket oder Pharma Paket, englisch: Pharma Package) ist ein Maßnahmenbündel der Europäischen Kommission zur Verbesserung der Arzneimittelsicherheit in der EU. Wesentliche Inhalte sind die: Verbesserung der… … Deutsch Wikipedia
European Economic Area — )legend|#000080|European Union member states ] The European Economic Area (EEA) came into being on 1 January 1994 following an agreement [PDFlink| [http://www.efta.int/content/legal texts/eea/EEAtext/EEAagreement/at download/file EEA Agreement] ] … Wikipedia
Adverse drug reaction — Classification and external resources Adverse drug reaction leading to hepatitis (drug induced hepatitis) with granulomata. Other causes were excluded with extensive investigations. Liver biopsy … Wikipedia
Adverse effect (medicine) — In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as chemotherapy or surgery. An adverse effect may be termed a side effect (when judged to be secondary to a main or… … Wikipedia
Adverse event — An adverse event (AE) is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a… … Wikipedia
Serious adverse event — A serious adverse event (SAE) in human drug trials are defined as any untowardmedical occurrence that at any dose results in #death, #is life threatening #requires inpatient hospitalization or prolongation of existing hospitalization #results in… … Wikipedia