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,…
We are proud to announce that the Le Monde newspaper, in its Science & Medicine insert, has recently published an article about our project with an interview with Pr. Régis Hankard of the paediatric clinical research network, Pedstart. The article highlights the important issue that drug development is all too often overlooked when it comes to paediatric care. He…
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…
