Advisory Committee for Therapeutics (ACT) toolkit – Conflict of interest (CoI) form template

Published by UNEW

Advice Clinical Development Clinical Trial Design Preclinical Research Research and Drug Development Translational Research TREAT-NMD

This conflict of interest form template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.

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Advisory Committee for Therapeutics (ACT) toolkit – Pre-application form template

Published by UNEW

Advice Clinical Development Clinical Trial Design Preclinical Research Research and Drug Development Translational Research TREAT-NMD

This pre-application form template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.

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Advisory Committee for Therapeutics (ACT) toolkit – Report to applicant template

Published by UNEW

Advice Clinical Development Clinical Trial Design Preclinical Research Research and Drug Development Translational Research TREAT-NMD

This report to the applicant template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.

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Advisory Committee for Therapeutics (ACT) toolkit

Published by UNEW

Advice Clinical Development Preclinical Research Research and Drug Development Toolkits for patients Translational Research TREAT-NMD

The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. An ACT can provide independent and objective advice to industry and academia, on a real-life therapeutic pathway of drug development programmes. An ACT review can help an applicant to position a candidate compound along a realistic and well-informed pathway to clinical trial and eventual
registration.

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Advisory Committee for Therapeutics (ACT) toolkit – Agenda Template

Published by UNEW

Advice Clinical Development Clinical Trial Design Preclinical Research Research and Drug Development Translational Research TREAT-NMD

This agenda template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.

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Advisory Committee for Therapeutics (ACT) toolkit – Applicant agreement template

Published by UNEW

Advice Clinical Development Clinical Trial Design Preclinical Research Research and Drug Development Translational Research TREAT-NMD

This applicant agreement template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit.

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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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Advisory Committee for Therapeutics (ACT) toolkit – Conflict of interest (CoI) form template

Advisory Committee for Therapeutics (ACT) toolkit – Pre-application form template

Advisory Committee for Therapeutics (ACT) toolkit – Report to applicant template

Advisory Committee for Therapeutics (ACT) toolkit

Advisory Committee for Therapeutics (ACT) toolkit – Agenda Template

Advisory Committee for Therapeutics (ACT) toolkit – Applicant agreement template