http___linguance.com_bs_oblasti_medicina-i-bioloske-nauke_farmakovigilanca-izvjestavanje-o-sigurnosti__1.xml
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Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance regulatory authorities around the globe: In the U.S., with about a third of all global 2014 pharmaceutical expenditures, the drug industry is regulated by the FDA, the largest national drug regulatory authority in the world. U.S. federal government provides for significant input from both the legislative and executive branches, which also play specific, distinct roles in determining FDA policy. Pharmacovigilance efforts in the EU are coordinated by the European Medicines Agency (EMA) and are conducted by the national competent authorities (NCAs). The main responsibility of the EMA is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community; the data processing network and management system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions. In conjunction with this oversight, individual countries maintain their distinct regulatory agencies with pharmacovigilance responsibility. In Canada by the Food and Drugs Act. The term medical devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration. Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function. Request Our Services
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Farmakovigilanca (PV ili PhV), također poznata kao sigurnost lijekova, farmakološka je nauka koja se bavi otkrivanjem, ocjenjivanjem, praćenjem i prevencijom nuspojava farmaceutskih proizvoda. Farmakovigilanca je definisana kao nauka ili aktivnost povezana sa otkrivanjem, ocjenjivanjem, razumijevanjem i prevencijom nuspojava i drugih problema u vezi s lijekovima. Regulatorna tijela za farmakovigilancu širom svijeta: Sjedinjene Američke Države U SAD, na koje se odnosi oko trećine svih svjetskih farmaceutskih izdataka u 2014. godini, industrijom lijekova upravlja FDA (najveće nacionalno regulatorno telo na svetu). Savezna vlada SAD pruža značajan doprinos kroz zakonodavnu i izvršnu vlast, što također igra određenu, specifičnu ulogu u određivanju politike FDA. Farmakovigilancu u EU koordinira Evropska agencija za lijekove (EMA), a sprovode je nadležna nacionalna tijela (NCA). Glavna odgovornost EMA je održanje i razvijanje baze podataka o farmakovigilanci koja se sastoji od svih potencijalnih ozbiljnih nuspojava lijekova primećenih u Evropskoj zajednici. Mreža za obradu podataka i upravljački sistem naziva se EudraVigilance i sadrži zasebne, ali slične, baze podataka nuspojava kod ljudi i životinja. U kombinaciji s tim nadzorom, pojedinačne zemlje održavaju svoje specijalne regulatorne agencije zadužene za farmakovigilancu. U Kanadi, prema Zakonu o hrani i lijekovima, termin „medicinski proizvod“ podrazumijeva širok spektar zdravstvenih i medicinskih instrumenata za liječenje, ublažavanje, dijagnostiku i prevenciju bolesti ili abnormalnih fizičkih stanja. Organizacija Health Canada ispituje medicinske proizvode u pogledu sigurnosti, efikasnosti i kvaliteta prije nego se dozvoli njihova prodaja u Kanadi. Klasifikacija medicinskih proizvoda u Australiji je opisana u odjeljku 41BD Zakona o terapeutskim proizvodima iz 1989. godine, te u članku 3.2 Uredbe o terapeutskim proizvodima iz 2002. godine, pod kontrolom Uprave za terapeutske proizvode. Farmakovigilanca je proces i nauka praćenja sigurnosti lijekova i preduzimanja mjera smanjenja rizika i povećanja koristi od lijekova. To je ključna funkcija javnog zdravstva. Zatražite naše usluge