Rezultaty
Report summarizing the relevant standardization landscape and appliable standards
Roadmap for adoption of PAT and Digital Twin Technologies (including regulatory compliance requirements)Report that will consist in a summary review of SoA of PAT and Digital Twin adoption in European Pharmaceutical industry; a SWOT analysis to feed into an Opportunities Roadmap that also takes account of the regulatory hurdles, as well as recommendations for a favorable/enabling regulatory framework, without compromising safety.
"Concept paper on ""compliance-by-design"" key-drivers and roadmap of the possible regulatory pathways or relevant regulatory frameworks for the required ""compliance-by-design"" strategies"Concept paper that reviews the latest developments in the scientific review, regulation, and marketing authorization procedures in the respective fields (related to the ETERNAL technological processes and developments) to inform a ‘compliant-by-design’ strategy in relation to the developments as part of the ETERNAL cocreation process.
Report on the contribution to standardizationReport outlining the contribution the project has/will make to standards.
Research roadmap and inventory of tools for the integration of existing knowledge into pharma risk assessmentPublic report that documents a research roadmap for the integration of scientific and regulatory knowledge into pharmaceutical risk assessment for fate modelling, bioavailability assessment and receptor identification, for regulatory testing and assessment, and inventory of tools for the integration of existing knowledge into pharma risk assessment.
Project website.
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