FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2281903791> ?p ?o ?g. }

• W2281903791 abstract "Background The LENA (Labeling of Enalapril from Neonates up to Adolescents) project has been initiated to improve the healthcare of children with heart failure by an enalapril orodispersible mini-tablet. The LENA consortium combines academic clinical research centers, SMEs (small and medium-sized enterprises) and a patient/parent advocacy organization. The objective of the project requires to comply with respective GxP regulations like Good Manufacturing Practice (GMP), Good Clinical (Laboratory) Practice (GCP/“GCLP”1) and Good Vigilance Practice (GVP). The project team is comprised of sub-teams experienced in paediatric clinical practice, medicines development, clinical research and project management, but not all team members work in an appropriate quality framework. Aim: To establish a well-documented, efficient quality system applying a new approach for ensuring quality in all trial aspects by combining existing organization-related quality system elements of the project partners with newly developed SOPs and overarching, integrating trial-specific elements to ensure a reliable quality environment for the LENA Phase I clinical trial. Methods Based on the network-structure of the project organization, a strategy based on a team approach with joint responsibilities for the quality conduct of the project was pursuit, forming a QM Team consisting of the project leader, the leaders for pharmaceutical and clinical development and an external quality expert. The team compiled a quality manual and an organizational chart displaying the sub-teams and their responsibilities. Another responsibility of the team is the integration of existing SOPs and Work Instructions as well as the creation of procedures at the project level and furthermore the verification of appropriate qualification of all staff involved in the project through CVs, job descriptions and training records. Results For the Phase I study, a thorough analysis of all existing relevant SOPs and Work Instructions, forms and other quality elements was performed, uncovered trial-related processes were identified and a work plan was established to fill the gaps with the smallest possible number of newly developed organization-related SOPs/Work Instructions and by preparing trial-specific process manuals. Demonstration of the trial team members was ensured by completing documentation concerning CVs, job description and training records. Among the sub-teams, the GCLP environment of the bioanalytical laboratory was started from scratch and could adequately support the LENA Phase I study by “GCLP” quality work and sample logistics. Conclusion The consortiums approach enabled the preparation of a comprehensive, reliable GxP compliant quality system within a short timeframe and with the limited resources of a publicly funded project. 1 “GCLP” is used as acronym for a quality system established in compliance with “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples” (EMA/INS/GCP/532137/2010; 28 February 2012) The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA)." @default.
• W2281903791 created "2016-06-24" @default.
• W2281903791 creator A5003423758 @default.
• W2281903791 creator A5031306133 @default.
• W2281903791 creator A5045753888 @default.
• W2281903791 creator A5048749853 @default.
• W2281903791 creator A5058993368 @default.
• W2281903791 creator A5068183995 @default.
• W2281903791 creator A5083821161 @default.
• W2281903791 date "2015-12-14" @default.
• W2281903791 modified "2023-09-25" @default.
• W2281903791 title "DEVELOPMENT AND ESTABLISHMENT OF A QUALITY-FRAMEWORK FOR THE LENA PROJECT" @default.
• W2281903791 doi "https://doi.org/10.1136/archdischild-2015-310148.72" @default.
• W2281903791 hasPublicationYear "2015" @default.
• W2281903791 type Work @default.
• W2281903791 sameAs 2281903791 @default.
• W2281903791 citedByCount "0" @default.
• W2281903791 crossrefType "journal-article" @default.
• W2281903791 hasAuthorship W2281903791A5003423758 @default.
• W2281903791 hasAuthorship W2281903791A5031306133 @default.
• W2281903791 hasAuthorship W2281903791A5045753888 @default.
• W2281903791 hasAuthorship W2281903791A5048749853 @default.
• W2281903791 hasAuthorship W2281903791A5058993368 @default.
• W2281903791 hasAuthorship W2281903791A5068183995 @default.
• W2281903791 hasAuthorship W2281903791A5083821161 @default.
• W2281903791 hasConcept C105795698 @default.
• W2281903791 hasConcept C111472728 @default.
• W2281903791 hasConcept C127413603 @default.
• W2281903791 hasConcept C138885662 @default.
• W2281903791 hasConcept C142724271 @default.
• W2281903791 hasConcept C144133560 @default.
• W2281903791 hasConcept C159319019 @default.
• W2281903791 hasConcept C15952604 @default.
• W2281903791 hasConcept C160735492 @default.
• W2281903791 hasConcept C162324750 @default.
• W2281903791 hasConcept C184356942 @default.
• W2281903791 hasConcept C187736073 @default.
• W2281903791 hasConcept C190812933 @default.
• W2281903791 hasConcept C195094911 @default.
• W2281903791 hasConcept C198783460 @default.
• W2281903791 hasConcept C201289532 @default.
• W2281903791 hasConcept C21547014 @default.
• W2281903791 hasConcept C2777205345 @default.
• W2281903791 hasConcept C2778150722 @default.
• W2281903791 hasConcept C2779530757 @default.
• W2281903791 hasConcept C33923547 @default.
• W2281903791 hasConcept C41008148 @default.
• W2281903791 hasConcept C50522688 @default.
• W2281903791 hasConcept C535046627 @default.
• W2281903791 hasConcept C56739046 @default.
• W2281903791 hasConcept C71405471 @default.
• W2281903791 hasConcept C71924100 @default.
• W2281903791 hasConcept C95981495 @default.
• W2281903791 hasConceptScore W2281903791C105795698 @default.
• W2281903791 hasConceptScore W2281903791C111472728 @default.
• W2281903791 hasConceptScore W2281903791C127413603 @default.
• W2281903791 hasConceptScore W2281903791C138885662 @default.
• W2281903791 hasConceptScore W2281903791C142724271 @default.
• W2281903791 hasConceptScore W2281903791C144133560 @default.
• W2281903791 hasConceptScore W2281903791C159319019 @default.
• W2281903791 hasConceptScore W2281903791C15952604 @default.
• W2281903791 hasConceptScore W2281903791C160735492 @default.
• W2281903791 hasConceptScore W2281903791C162324750 @default.
• W2281903791 hasConceptScore W2281903791C184356942 @default.
• W2281903791 hasConceptScore W2281903791C187736073 @default.
• W2281903791 hasConceptScore W2281903791C190812933 @default.
• W2281903791 hasConceptScore W2281903791C195094911 @default.
• W2281903791 hasConceptScore W2281903791C198783460 @default.
• W2281903791 hasConceptScore W2281903791C201289532 @default.
• W2281903791 hasConceptScore W2281903791C21547014 @default.
• W2281903791 hasConceptScore W2281903791C2777205345 @default.
• W2281903791 hasConceptScore W2281903791C2778150722 @default.
• W2281903791 hasConceptScore W2281903791C2779530757 @default.
• W2281903791 hasConceptScore W2281903791C33923547 @default.
• W2281903791 hasConceptScore W2281903791C41008148 @default.
• W2281903791 hasConceptScore W2281903791C50522688 @default.
• W2281903791 hasConceptScore W2281903791C535046627 @default.
• W2281903791 hasConceptScore W2281903791C56739046 @default.
• W2281903791 hasConceptScore W2281903791C71405471 @default.
• W2281903791 hasConceptScore W2281903791C71924100 @default.
• W2281903791 hasConceptScore W2281903791C95981495 @default.
• W2281903791 hasLocation W22819037911 @default.
• W2281903791 hasOpenAccess W2281903791 @default.
• W2281903791 hasPrimaryLocation W22819037911 @default.
• W2281903791 hasRelatedWork W1169560692 @default.
• W2281903791 hasRelatedWork W1479954657 @default.
• W2281903791 hasRelatedWork W2031917593 @default.
• W2281903791 hasRelatedWork W2062678926 @default.
• W2281903791 hasRelatedWork W2102228018 @default.
• W2281903791 hasRelatedWork W2174835715 @default.
• W2281903791 hasRelatedWork W2417087201 @default.
• W2281903791 hasRelatedWork W2617115642 @default.
• W2281903791 hasRelatedWork W2768529951 @default.
• W2281903791 hasRelatedWork W2783423190 @default.
• W2281903791 hasRelatedWork W2889274185 @default.
• W2281903791 hasRelatedWork W2947290784 @default.
• W2281903791 hasRelatedWork W2997080825 @default.
• W2281903791 hasRelatedWork W2998073744 @default.
• W2281903791 hasRelatedWork W3027610210 @default.
• W2281903791 hasRelatedWork W3030608921 @default.

• next