Published by IRDiRC
GuidelinePatient RegistryRare DiseaseResearch and Drug DevelopmentFAIRLack of ultimate data use in rare disease created many silos slowing down development. The FAIR is coming to bridge this gap by proving essential guidelines for optimal data use.
View this resource Bookmark this resourcePublished by WHO Technical Report Series
GuidelineVaccineNonclinical StudiesToxicityThis document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vaccines by outlining the international regulatory expectations in this area.
View this resource Bookmark this resourcePublished by European Commission (EC)
Clinical Trials ToolkitGuidelineToolboxQuick guide on the rules and procedures of the EU Clinical Trials Regulation drawn up by the Clinical Trials Coordination and Advisory Group (CTAG) as its members are the National Contact Points defined in the above mentioned Regulation
View this resource Bookmark this resourcePublished by GoodtrialsECRIN
Clinical Trials ToolkitGuidelineThe guidance is intended to support all individuals and organizations involved in the planning, conduct, analysis, oversight, interpretation, funding, and regulation of RCTs of any health intervention for any purpose in any setting.
View this resource Bookmark this resourceThis toolkit aims to provide a guide for researchers, charities and others embarking on repurposing projects. It highlights common activities, issues and considerations at each development stage and signpost to other available resources. The content is mostly styled as questions – what should I be considering at each development stage? It is intended to stimulate thinking and not as a step-by-step guide, which reflects the variable nature of repurposing.
View this resource Bookmark this resourcePublished by IRDiRC
GuidelineFAIRResearch and Drug DevelopmentRare DiseasePatient RegistryLack of ultimate data use in rare disease created many silos slowing down development. The FAIR is coming to bridge this gap by proving essential guidelines for optimal data use.
View this resource Bookmark this resourcePublished by EMA
GuidelineSerious BreachesRegulation 536/2014Clinical Trial ProtocolThis document describes the guideline for the notification of serious breaches of
Regulation (EU) No 536/2014
Published by Biomarker Commercialization (BIC) consortium
Research and Drug DevelopmentBiomarkerGuidelineBiomarker Commercialisation (BIC) ConsortiumThe BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide.
View this resource Bookmark this resourcePublished by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
GuidelineEMAPharmacogenomicsGenomic DataSample CodingThis guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories.
View this resource Bookmark this resourcePublished by WHO Technical Report Series
GuidelineVaccineNonclinical StudiesToxicityThis document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the nonclinical evaluation of vaccines by outlining the international regulatory expectations in this area.
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