First c4c Multi-Stakeholder Meeting on Paediatric Inflammatory Bowel Disease (IBD) More than 100 stakeholders from academia, industry, regulators and patients/patient associations attended our first Multi-Stakeholder Meeting (MSM) on April 14 and 15, 2021. Background MSMs are designed to facilitate discussion and interaction among relevant stakeholders on the development of medicines in the best interest of children…
Strategic feasibility expert advice groups One of the key activities of c4c is to set up an advice process to facilitate expert advice, (Strategic Feasibility Advice) to c4c industry and academic beneficiaries on any aspect of a paediatric drug research and/or development project (e.g., study design including methodology, assistance with regulatory responses). More than 300…
Patient and Public Involvement (PPI) The voice of the patient in clinical research and development is increasingly being included, from the setting of research priorities through to the dissemination of results. This marks a shift in what has historically and culturally been, until relatively recently, research “on” rather than “with” patients. Previously, researchers defined their…
What are the c4c National Hubs (NHs)? Paediatric research has multiple challenges and these challenges become obstacles when the research infrastructure is not well-prepared to overcome them. There is a huge need to work in a coordinated way, between multiple partners and countries, to improve the design and implementation of paediatric trials. c4c has sought…
Introducing the c4c project leadership team: Carlo Giaquinto (Penta – project coordinator) Mark Turner (University of Liverpool – co-coordinator) Katharine Cheng (Janssen – project lead) Heidrun Hildebrand (Bayer – co-project lead). We lead and supervise the overall progress of c4c, with the support of the project management office, and by working closely with Work Package…
What are patients’ needs and how to improve the development of medicines? First c4c Multi-Stakeholder Meeting on paediatric Inflammatory Bowel Disease (IBD). c4c held its first International Multi-Stakeholder Meeting (MSM) on paediatric Inflammatory Bowel Disease (IBD) virtually on 14-15 April 2021. Over 100 individuals participated, representing patients and advocates, clinicians, academics, pharmaceutical companies and regulators.…
In c4c, we are creating an integrated educational program, developed jointly by academia and industry companies, to address best practice in paediatric clinical trials and paediatric medicine development. So far, 31 courses have been developed within our consortium in the fields of: Good Clinical Practice (GCP basic courses) Competence Development courses in Good Clinical Practice…
The voice of the patient in clinical research and development is increasingly being taken into account, from the setting of research priorities right through to dissemination of results. This marks a shift in what has historically and culturally been seen, until relatively recently, as research “on” rather than “with” patients. PPI is an inherent part…
Clinical trials are an essential part of advancing knowledge and improving healthcare worldwide. Advances in paediatric research across the globe to improve the lives of babies, children and young people have dramatically reduced rates in morbidity and mortality and increased the quality of life, for example, reducing sudden infant death, increasing the life expectancy for…
c4c held the first workshop on Young Persons Advocacy Groups (YPAG) for the PPI liaisons in the National Hubs on the 28 January and 4 February held over ZOOM virtual meeting platform. In case you are not familiar with this term, A Young Persons Advisory Group (YPAG) is a group made up of children and…
