Two small girls

Paediatric pharmacovigilance

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper by Aurich et al British Journal of Clinical Pharmacology – Wiley Online Library Children frequently respond differently to therapies compared to adults. Differences also exist between Paediatric age groups for pharmacokinetics and pharmacodynamics in both…

c4c team presentation post: Lionel Tan

Meet the team behind c4c! We are a diverse group of people from many different backgrounds, but all of us are working towards a common goal: better medicines for children through European clinical trials.   Today’s spotlight is on Lionel Tan, one of the industry representatives helping to steer the direction of c4c. Lionel Tan…

Clinical Data Modelling

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium The c4c have published a new article on the Direcht clinical data modelling tool in Applied Sciences.  “c4c is piloting the Direcht clinical data modelling tool to model their Cross Cutting…

Health Technology Assessment of Paediatric Medicines

c4c have published ‘Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project” in British Journal of Clinical Pharmacology.   “The medicine development process is complex and requires time and effort to ensure safety, efficacy and quality. In paediatrics, this process is even more challenging, as it involves a subgroup of…

Spotlight on a National Hub: Spain

Back in November 2016, the first meeting for the constitution of RECLIP was held at La Paz Research Institute in Madrid (IdiPAZ). By that time, the network consisted of 12 reference hospitals, the Foundation for the Promotion of Health and Biomedical Research (FISABIO) and 2 research networks RITIP (Translational Research Network in Pediatric Infectious Diseases)…

How patients can be involved in paediatric clinical trials at regulatory level? (Interview with EURORDIS-Rare Diseases Europe)

Maria Cavaller (Patient Engagement Manager) and Gulcin Gumus (Research and Policy Project Manager) are from patient organisation EURORDIS-Rare Diseases Europe, which is a c4c project partner. We talked to them about how patient organizations can take part in the c4c project, the importance of engaging young patients in research and having patients as equal partners…