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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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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EU planned cross-border treatments

Published by IRDiRC

Early Access Support EU Planned Cross-Border Treatment Orphan Drug Patient Information Research and Drug Development

Different ways to access the health care structures and professionals of the foreign EU Country National Health System (NHS) for people insured in the EU countries.

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Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Clinical Development Early Access Support FDA Regulatory Advice Patient Advice Patient Affairs Staff Patient Engagement Patient Support Regulatory Affairs Research and Drug Development

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Regulatory Guide for Translational Research

Published by EATRIS

Early Access Support Regulatory Sciences Research and Drug Development Scientific Guidelines Regulations

Regulatory Database

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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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