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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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 – 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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EMA Scientific guidelines

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Clinical Development Clinical Trial Design Guideline Regulatory Advice Regulatory Affairs

The European Medicines Agency’s Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Clinical Development Clinical Trial Design Regulatory Advice Regulatory Affairs Special Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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Extrapolation of efficacy and Safety in medicine development

Published by IRDiRC

Adaptative Pathways Clinical Development Clinical Trial Design Extrapolation of Efficacy and Safety Regulatory Sciences Research and Drug Development Study Design Target Population

The EMA describes extrapolation as extending information and conclusions available from studies in one or more subgroups of the patient population (source population(s)), or in related conditions or with related medicinal products, in order to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the amount of, or general need for, additional evidence generation (types of studies, design modifications, number of patients required) needed to reach conclusions.

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Alternative designs for Small Population Clinical Trials

Published by IRDiRC

Adaptative Pathways Clinical Development Clinical Trial Clinical Trial Design Rare Disease Regulatory Sciences Small Population

Guidance and general recommendations are available to select the most efficient study design for each medical condition or trial, and on potential adaptions of conventional designs to the low sample size scenario.

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Adaptive Pathways

Published by IRDiRC

Adaptative Pathway Clinical Development Clinical Trial Design Early Access Support Regulatory Affairs

The adaptive pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines

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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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