Clinical Trial

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Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)

Published by EC

investigational medicinal productsMedicinal ProductsClinical Trial

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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Advisory Committee for Therapeutics (ACT) Toolkit

Published by Newcastle University

NeuromuscularResearch and Translational ResourceNetworkExpert AdviceClinical Trial

The TREAT-NMD Advisory Committee for Therapeutics (TACT) is a unique multi-disciplinary model centred upon an international group of academic and industry drug development experts, including patient representatives. TACT gives advice on the translational and development pathway of therapeutic programs in rare Neuromuscular Diseases. Due to its success in the neuromuscular field, a toolkit to replicate the TACT model has been produced. The Advisory Committee for Therapeutics (ACT) toolkit is intended to support rare disease communities outside of Neuromuscular to establish their own ACT, by providing them with step-by-step guidance and template documentation.

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Clinical trials – Regulation EU No 536/2014

Published by EMA

Clinical TrialRegulation

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements

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