Translational Research

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Advisory Committee for Therapeutics (ACT) toolkit

Published by UNEW

AdviceClinical DevelopmentPreclinical ResearchResearch and Drug DevelopmentToolkits for patientsTranslational ResearchTREAT-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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European Paediatric Translational Research Infrastructure (EPTRI)

Published by EPTRI

Drug DevelopmentpaediatricRegulatory Affairsresearch infrastructureTranslational Research

The EPTRI Centralised Services are provided by the EPTRI CMO and dedicated experts. These services include:
*Providing access to paediatric patients’ cohorts
*Providing access to paediatric samples and related data
*Advice on in-vivo / in-silico non-clinical study design
*Advice on in-vivo / in-silico clinical study design
*Advice and document preparation for regulatory and ethics procedures
*Advice on preparing HTA reports for paediatric medicines, diagnostics, and medical devices
*Advice on data and sample sharing preparation
*Support with applications to public and private funding opportunities

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Secretariat of the Convention on Biological Diversity. Nagoya Protocol On Access To Genetic Resources And The Fair And Equitable Sharing Of Benefits Arising From Their Utilization To The Convention On Biological Diversity. Canada, 2011. ISBN: 92-9225-306-9.

Published by United Nations

Genetic ResourcesNagoya ProtocolTranslational Research

The Protocol  provides
a strong basis for greater legal certainty and transparency for both providers
and users of genetic resources. It also promotes the use of genetic resources and associated traditional knowledge,  strengthens the opportunities for fair and equitable sharing of benefits from their use. 

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