European Medicines Agency. Committee for Medicinal Products for Human Use. ICH Guideline S11 on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals. Step 5. 31 March 2020. EMA/CHMP/ICH/616110/2018.

Published by European Medicines Agency (EMA)

Animal Models EMA Guideline Non-Clinical Trials Paediatrics Pharmaceuticals Toxicity

This guideline recommends an approach for the nonclinical safety evaluation of pharmaceuticals intended for development in paediatric populations. This can include products with prior adult use, as well as products being considered for initial human use in paediatrics

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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications. 2008 (EMEA/CHMP/SWP/169215/2005).

Published by European Medicines Agency (EMA)

Animal Models EMA Guideline Juvanile Animals Non-Clinical Testing Paediatric Indications

This document provides guidance on the need for, role and timing of studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It is applicable to initial medicinal products applications and also to authorised medicinal products being further developed to include paediatric indications. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials.

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European Medicines Agency. Committee for Advanced Therapies (CAT). Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells. 3 November 2020. EMA/CAT/GTWP/671639/2008 Rev. 1

Published by EMA

Clinical Aspects Genetically Modified Cell Guideline Non-Clinical Quality

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

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Biomarker Commercialization Review Tool

Published by Biomarker Commercialization (BIC) consortium

Biomarker Biomarker Commercialisation (BIC) Consortium Guideline Research and Drug Development

The 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.

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FAIR principle for data use

Published by IRDiRC

FAIR Guideline Patient Registry Rare Disease Research and Drug Development

Lack 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.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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