FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2889573658> ?p ?o ?g. }

• W2889573658 abstract "Transfusion and plasma fractionation in France are closely linked to the historical reliance on voluntary unpaid blood donation that constitutes the foundation in the national system for the supply of labile blood components and stable fractionated plasma products. From 1993, three successive laws on safety of blood and medicines have been implemented to separate the missions of the stakeholders leading to clearly distinguish the mission of producers and regulatory bodies: operator for the blood sector, Etablissement Francais du Sang (EFS), operator for the fractionation into medicines, Laboratoire francais du Fractionnement et des Biotechnologies (LFB), and the regulator, the French National Agency for the Safety of Medicines and Health Products (ANSM). LFB has received the mandate of manufacturing fractionated plasma products from the plasma collected by EFS and to serve as a priority the needs of French patients. Since 1989, the European Union has built the regulatory framework for stable products, which are considered as medicinal products derived from human blood or human plasma. Many European legal and regulatory organisations supervise quality, biological safety, clinical safety, and efficacy of both blood components and medicinal products derived from human plasma. Guidelines, monographs, good practices (GXP or blood good practices) and others regulatory documents prompt operators to comply with these requirements, whereas operators, by improving their manufacturing practices, lead the regulation to adapt to innovation. France addresses these requirements in many legal and regulatory texts, most transposed from European legislation. While the two sectors are regulated in France by one unique national competent authority, the European Medicines Agency (EMA) does not include blood and blood components regulation under its responsibility. The safety and protection of donors is still carried out by the collegial cooperation of European and international operators. The European Commission has started to reflect on substances for human origin regulations as a whole, and a revision of the blood directive might lead to adapted definitions of voluntary, non-remunerated blood donations [including for plasma for fractionation (PfF)] in order to further protect the human body and its parts and to promote appropriate supply of European plasma." @default.
• W2889573658 created "2018-09-27" @default.
• W2889573658 creator A5022941983 @default.
• W2889573658 date "2018-09-01" @default.
• W2889573658 modified "2023-10-18" @default.
• W2889573658 title "The organization of transfusion and fractionation in France and its regulation" @default.
• W2889573658 cites W2107836315 @default.
• W2889573658 cites W2401865216 @default.
• W2889573658 doi "https://doi.org/10.21037/aob.2018.05.01" @default.
• W2889573658 hasPublicationYear "2018" @default.
• W2889573658 type Work @default.
• W2889573658 sameAs 2889573658 @default.
• W2889573658 citedByCount "1" @default.
• W2889573658 countsByYear W28895736582018 @default.
• W2889573658 crossrefType "journal-article" @default.
• W2889573658 hasAuthorship W2889573658A5022941983 @default.
• W2889573658 hasBestOaLocation W28895736581 @default.
• W2889573658 hasConcept C108170787 @default.
• W2889573658 hasConcept C111472728 @default.
• W2889573658 hasConcept C121955636 @default.
• W2889573658 hasConcept C127413603 @default.
• W2889573658 hasConcept C138885662 @default.
• W2889573658 hasConcept C144133560 @default.
• W2889573658 hasConcept C155202549 @default.
• W2889573658 hasConcept C17744445 @default.
• W2889573658 hasConcept C199539241 @default.
• W2889573658 hasConcept C21547014 @default.
• W2889573658 hasConcept C2775884135 @default.
• W2889573658 hasConcept C2777351106 @default.
• W2889573658 hasConcept C2779709869 @default.
• W2889573658 hasConcept C2780511413 @default.
• W2889573658 hasConcept C2910001868 @default.
• W2889573658 hasConcept C2991908516 @default.
• W2889573658 hasConcept C3116431 @default.
• W2889573658 hasConcept C71924100 @default.
• W2889573658 hasConceptScore W2889573658C108170787 @default.
• W2889573658 hasConceptScore W2889573658C111472728 @default.
• W2889573658 hasConceptScore W2889573658C121955636 @default.
• W2889573658 hasConceptScore W2889573658C127413603 @default.
• W2889573658 hasConceptScore W2889573658C138885662 @default.
• W2889573658 hasConceptScore W2889573658C144133560 @default.
• W2889573658 hasConceptScore W2889573658C155202549 @default.
• W2889573658 hasConceptScore W2889573658C17744445 @default.
• W2889573658 hasConceptScore W2889573658C199539241 @default.
• W2889573658 hasConceptScore W2889573658C21547014 @default.
• W2889573658 hasConceptScore W2889573658C2775884135 @default.
• W2889573658 hasConceptScore W2889573658C2777351106 @default.
• W2889573658 hasConceptScore W2889573658C2779709869 @default.
• W2889573658 hasConceptScore W2889573658C2780511413 @default.
• W2889573658 hasConceptScore W2889573658C2910001868 @default.
• W2889573658 hasConceptScore W2889573658C2991908516 @default.
• W2889573658 hasConceptScore W2889573658C3116431 @default.
• W2889573658 hasConceptScore W2889573658C71924100 @default.
• W2889573658 hasLocation W28895736581 @default.
• W2889573658 hasOpenAccess W2889573658 @default.
• W2889573658 hasPrimaryLocation W28895736581 @default.
• W2889573658 hasRelatedWork W2017085932 @default.
• W2889573658 hasRelatedWork W2128924865 @default.
• W2889573658 hasRelatedWork W2249394492 @default.
• W2889573658 hasRelatedWork W2389559237 @default.
• W2889573658 hasRelatedWork W2618700624 @default.
• W2889573658 hasRelatedWork W2969403942 @default.
• W2889573658 hasRelatedWork W3112376189 @default.
• W2889573658 hasRelatedWork W3123918520 @default.
• W2889573658 hasRelatedWork W3157385118 @default.
• W2889573658 hasRelatedWork W242155191 @default.
• W2889573658 isParatext "false" @default.
• W2889573658 isRetracted "false" @default.
• W2889573658 magId "2889573658" @default.
• W2889573658 workType "article" @default.