The c4c consortium works to create the infrastructures, processes and relationships that will allow the network to optimize the delivery of clinical trials in children and adolescents concerning all conditions – including psychiatric disorders. At the 32nd ECNP Congress on 7th-10th September 2019, the European Child and Adolescent Clinical Psychopharmacology Network (ECAPN), an initiative of…
c4c is about to launch its first online training course – the PAEDIATRIC GCP BASIC ONLINE COURSE. It is available to the c4c network’s site staff and healthcare professionals involved in the c4c supported clinical trials. If you are interested, please get in contact with your National Hub. The PAEDIATRIC GCP BASIC ONLINE COURSE, accredited by…
We encourage patients and their families to get involved in c4c activities. The active participation of children, young people and their carers is one of the key objectives of the project. Some good examples of activities in which patients will be involved include protocol revision and meetings to discuss paediatric unmet needs. If you wish…
We are delighted to announce the selection of the c4c consortium’s first portfolio of pan-European paediatric studies aimed at advancing the understanding of high priority medicines commonly used in babies, children and young people in Europe. The four inaugural studies will be conducted by academic institutions, in addition to three or four studies by industry…
The c4c consortium has issued a call for tender for subcontracting a specialised business school or company that can assist in the development of a sustainable business model for a pan-European paediatric clinical trials network. An important element of c4c is the push for a well-functioning business model and long-term sustainability, making sure that the network will continue to assume its pivotal…
The European Medicines Agency (EMA) has recently published a booklet covering the process undertaken for medicines for human use and which are authorised through the EU centralised procedure. With a user-friendly layout, it communicates the steps that are taken from the initial research stages of a new medicine to when it is eventually marketed to…
We are now seeking experts interested to be part of Clinical or Methodology Expert Groups and who want to contribute at providing advice. One task of the c4c consortium is to deliver the scientific feasibility advice needed to improve child health and paediatric medicine development. Groups of experts (methodological, clinical, and parents/patients) will be set up to provide…
The countdown has begun to Rare Disease Day 2019 on 28th February. People around the world are joining the global movement for rare diseases by taking part in the #ShowYourRare campaign, holding events and raising awareness. There are over 6,000 rare diseases. The European Union considers a disease as rare when it affects less than 1 in 2,000…
Within the pan-European c4c framework, partner Fondazione Gianni Benzi Onlus needs to identify a list of economic operators to be invited to provide a proposal for the executive design, development and deployment of an IT platform. This platform must be compliant with industry standards and cover both functional (processes workflow, metrics, reports, dashboards, archiving, storage, etc.) and non-functional (regulatory,…
The European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) recently organised a workshop on 28th November 2018 in London to agree with various stakeholders on common European Union key principles to pave the way for implementing electronic product information (ePI) in the EU. Electronic formats are becoming ever…