National Regulatory Authorities in Europe
National Regulatory Agencies of European Member States
Regulatory authorities responsible for human medicines, including paediatric drug development and authorisation.
Paediatric medicines development and evaluation
European Medicines Agency
European body responsible for the scientific evaluation of medicines for use in the European Union. A focus on paediatric medicines development is also available.
Official website of the European Commission, where you can find information on law and policies, funding and public contracts and many other official information about the European Union.
Collection of rules and regulations governing medicinal products in the European Union.
EU Clinical Trials Register
Official source of information about interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA), clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. It is possible to perform an advanced search, by selecting paediatric clinical trials only.
Registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
International initiative to reach harmonisation for better global health worldwide, bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.
European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
Network of research networks, investigators and centres with recognised expertise in performing clinical studies in children, established at European level.
Global Research in Paediatrics (GRiP)
Network of scientists aimed at stimulating and facilitating the development and safe use of medicines in children.
EnprEMA Networks Database
Database of all research networks and centres with recognised expertise in performing clinical studies in children, hosted by Enpr-EMA.
The European Joint Programme on Rare Diseases is a EU funded project that brings over 130 institutions (including all 24 ERNs) from 35 countries to create a comprehensive, sustainable ecosystem allowing a virtuous circle between research, care and medical innovation. It aims to tackle challenges in the rare disease field to trigger the creation of an innovation pipeline “from bench to bedside” ensuring rapid translation of research results into clinical applications and uptake in healthcare for the benefit of patients.
TEDDY is actively involved in the project Communication and Dissemination actions as well as in the activities dedicated to the preparation and organisation of educational materials and initiatives for paediatric patients with chronic rare diseases. Annual Face to Face (F2F) will be organised on the themes of rare diseases to allow paediatric patients with rare diseases to get the right skills to be involved in research and make the difference in the experimental procedures.
European Paediatric Translational Research Infrastructure intended to enhance technology-driven paediatric research in drug discovery and early development phases to be translated into clinical research and paediatric use of medicines.
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