The project aims to tackle the scarcity of medical devices designed for children with orphan diseases. Its goal is to encourage the development of novel customised devices or the advancement of existing ones that accurately target paediatric unmet medical needs and address children’s anatomy and disease characteristics more effectively.

The project seeks to support patients living with rare disease by enhancing prevention, diagnosis, and treatment of new therapies, where often there are no therapeutic options. A comprehensive and multifaceted Network will facilitate the sharing of healthcare data, translation of research into medical interventions, patients’ empowerment, and upgraded communication with stakeholders.

The project aims to improve the evaluation of new medicines for rare diseases of paediatric relevance through the use of innovative designs, simulation methods, and real-world data approaches. This framework will improve the efficiency of the drug evaluation process by providing validated clinical evidence tools to help regulators make better and more informed decisions.

This project may serve as resources to facilitate comprehensive reporting needed to understand paediatric clinical trial protocols (SPIRIT-C) and reports (CONSORT-C), which may improve transparency within paediatric clinical trials and reduce research waste.  TEDDY is also a member of the SPIRIT|CONSORT-Children Explanation & Elaboration (E&E) Writing Team. The outputs will be disseminated through publications, academic conferences, and endorsement by paediatric journals and relevant research networks and organisations.

The European Joint Program on Rare Disease (EJP RD) is a programme aiming to create an effective rare diseases research ecosystem for progress and innovation, beneficial to anyone with a rare disease. Supporting rare diseases stakeholders by funding research, bringing together data resources & tools, providing dedicated training courses, and translating high quality research into effective treatments.

RESTORE represents a preparatory action for a large-scale research initiative aimed to shift from treating symptoms to curing chronic diseases by making the transformative promise of Advanced Therapies a reality. Advanced Therapies, in Europe categorised as Advanced Therapy Medicinal Products (ATMP), include medicinal products based on gene therapy, cell-therapy and tissue engineered products, as well as the combination of these products with medical devices such as biomaterials. A high degree of complexity has to be faced in their manufacturing, clinical use, and mode-of-action compared to conventional drugs or antibodies that RESTORE aimed to remove.

This Erasmus+ project aimed to create new Young Persons Advisory Groups (YPAGs) in Romania, Czech Republic and Greece following the experience of KIDS Bari and KIDS Albania, supported by TEDDY Network. During the exchange, the youths followed a training period characterised by “peer education” and “learning by doing” approaches, aimed to increase their engagement in health and research issues and learn how to be actively involved in the decisions concerning their own health. Also they learnt about planning, participation and evaluation of research involving children.

This was a three-year project that brought together the European Clinical Research Infrastructure Network (ECRIN) and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) for the management of multinational paediatric clinical trials, maintaining high quality and ethical standards. It will also represent a unique opportunity to attract more industry-sponsored trials and more Member and Observer countries, involving both scientific communities and government representatives in discussions among stakeholders.

SMART is a H2020 project aimed at enhancing innovative paediatric research methods at national and local level. In particular, the project is dedicated to raising the Instytut Pomnik Centrum Zdrowia Dziecka (IPCZD – Poland) staff’s research profile and implementing the leading role of this Institution in Europe. A specific training programme is foreseen including the organisation of staff exchanges, face to face courses and summer schools. These activities are oriented to share experience, promote cross-interaction among disciplines and institutions, boost the project’s cohesion and ensure the effective participation of all partners.

This project aimed to develop a new age-appropriate formulation of vancomycin and provide clinical data on adequate dosing regimen for neonates and infants, with the ultimate objective of applying for a PUMA.

A project aimed to develop and test a parenteral age-appropriate formulation of clonidine for sedation in Paediatric Intensive Care Units in order to obtain a PUMA

This project aimed to develop and test a new formulation of gabapentin for the treatment of neuropathic chronic pain in the paediatric population. Results from paediatric clinical studies will be used for a PUMA application

This was a worldwide network of scientists that aimed to stimulate and facilitate the development and safe use of medicines in children, with the implementation of a comprehensive training programme in paediatric clinical pharmacology and the integration of the existing paediatric research capacity.

A research project aiming to integrate the existing information on deferiprone use in the paediatric population with chronic iron overload. A new oral liquid formulation of deferiprone suitable for paediatric use has been developed and a PUMA application will be submitted at the end of the studies. Two clinical trials and an observational study in children are ongoing.

This project aims at studying pharmacokinetics, safety and efficacy of meropenem in comparison to standard care in neonates and infants aged less than 3 months affected by late-onset sepsis and bacterial meningitis. The results will be used for a PUMA application.

A partnership of several European universities and Health Institutions aiming to develop and implement a novel method of surveillance for antimicrobial consumption and resistance in children in hospitals and in primary care across Europe.

https://penta-id.org/severe-infections-and-antimicrobial-resistance/past-projects-antimicrobials/

This project aimed to identify the needs and motivations of children and their families participating in clinical trials in Europe. The project makes available recommendations for researchers about how to empower children, respect their rights and interests and motivate their participation in future clinical trials.

The overall aim of the TEDDY project was promoting the availability of safe and effective medicines for children in Europe (optimisation for the paediatric use of current drugs and promotion of the development of new drugs) by integrating existing expertise and good practices, as well as stimulating further developments also by let children benefit from breakthroughs in genomics, biotechnology, pharmacology and therapeutics.

The proposed network involved different stakeholders active in both the drug development sector and paediatric clinical practice. European academics, researchers, healthcare specialists and ethics experts will work together with pharmaceutical companies, regulatory agencies and patients associations to attain common objectives.