From lab to patient: journey of a medicine

Published by EMA

Centralised Procedure Committee for Orphan Medicinal Products EMA Drug Development EU Marketing Authorisation Road Map Marketing Authorisation National Procedure Regulatory Affairs Scientific Advice

Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the Safety of medicines.

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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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Flowchart

Published by Biomarker Commercialization (BIC) consortium

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

The Flowchart provides a simplified overview of the entire process from discovery to market maturity.

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Best Practices and Pitfalls in Commercializing IVD-applicable Biomarkers

Published by Biomarker Commercialization (BIC) consortium

Biomarker Biomarker Development IVD Research and Drug Development

This handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery, development, patent protection and technology transfer at universities, hospitals and research organizations.

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From laboratory to patient: the journey of a medicine assessed by EMA

Published by EMA

Committee for Orphan Medicinal Products EMA Drug Development EU Marketing Authorisation Road Map Marketing Authorisation Regulatory Affairs Scientific Advice

This booklet covers medicines for human use that are authorised via EMA through the EU centralised procedure.

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Guideline On Development And Manufacture Of Lentiviral Vectors

Published by EMA

Advanced Therapy ATMP Early Access Support Gene Therapy Lentiviral Vector Regulatory Affairs

This guideline describes quality aspects that are relevant for lentiviral vectors (LV). It applies to LV intended for ex vivo or in vivo application.

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Guideline On The Non-Clinical Studies Required Before First Clinical Use Of Gene Therapy Medicinal Products

Published by EMA

Advanced Therapy Early Access Support First Clinical Use Gene Therapy Non-Clinical Regulatory Affairs

This document defines scientific principles and provides guidance to applicants developing Gene Therapy medicinal products (GTMPs). It focuses on the non-clinical studies required before the first use of a GTMPs in human subjects.

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Quality, preclinical and clinical aspects of Gene Therapy medicinal products

Published by EMA

Advanced Therapy Cell Therapy clinical Gene Therapy Genetically Modified Cell Non-Clinical Quality somatic cell

Guide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.

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Clinical Trial Regulation

Published by EMA

Clinical Development Clinical Trial Design Regulatory Affairs

The goal of the Clinical Trial Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of Safety for participants and increased transparency of trial information.

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Paediatric Regulation

Published by EU

Early Access Support EMA Paediatric Regulation Official Journal Paediatric Medicine Paediatric Regulation Regulatory Affairs

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

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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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