Standardisation in Life Sciences - with CHARME towards a unified standardisation European strategy
Abstract
MotivationStandardisation and quality management are important drivers in the life sciences and biotechnology, as onlydata generated with minimum quality assurance can be easily implemented into industrial applications.Standards assure and ensure that data become easily accessible, shareable and comparable along the valuechain. Reproducibility, standards and standard operating procedures (SOPs) in data generation and analysisare challenging topics of the modern research and bioinformatics. Only by the use of common standardsEuropean life science research will improve its efficiency and competitiveness. In the past years severalinitiatives have been launched to develop and implement standards in life science research. Unfortunately,these efforts remain fragmented and largely disconnected. The Cost Action CHARME (CA15110) isdesigned as a central interface between existing standardisation initiatives, and as an intermediary betweenexisting parallel efforts. The goals of CHARME are: 1) to develop a framework for standardisation ofstandards and formats in life sciences; 2) community building/networking of scientific standardisationinitiatives; 3) development of a common understanding/definition of the subject matter; 4) to create a commonplatform for all stakeholders, for sustainable and efficient cooperation on standardisation and standardisation;5) mediation between the scientific standardisation initiatives and the competent standardisation bodies andstandards committees' activities (including input from stakeholders, e.g. standardisation bodies, policymakers, regulators, users); 6) the analysis and classification of existing (or developing) community standardsin the field of systems biology and computational modelling (and beyond); 7) to support the positioning ofEurope as a "leading partner" in international standardisation and standardisation activities in the life sciences(including input for future market applications and cooperation with private enterprises).MethodsCHARME's pan-European network unites experts from all areas of scientific research and strategicdevelopment (academia, industry, policy, legal, ethical, etc.), joining their expertise to address needs andchallenges along the value chain for life sciences across Europe. To achieve the Action's 4-year vision, anintegrated project strategy has been designed to ensure de-centralised decision-making and enhancedcooperation between the different stakeholders and partners. The leverage of the COST Action CHARMErelates to four pillars: 1) the creation of a network of all relevant stakeholder groups involved instandardisation, to exchange and harmonise activities; 2) the development of a cross-cutting education andtraining strategy to raise awareness and facilitate the implementation of standards and SOPs; 3) strengtheningof innovation creation and technology transfer; 4) strategy development to urge the implementation ofstandards and SOPs. This will be achieve
Autore Pugliese
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D'Elia D.; Regierer B.; Hollmann S.
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Anno di pubblicazione
2016
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