TINN2 is a European research network (Collaborative Project) supported by the European Commission under the Health Cooperation Work Programme of the 7 th Framework Programme.

News & Events

 

TINN European Survey on the Use of Antibiotics in NICUs

The survey results are now available and the published article has been published.

Please click here to consult it.

 

MANY THANKS to all the Neonatal Intensive Care Units that dedicated their time to partipate in the TINN2 survey.

 

Consortium final meeting on 8th October 2015, in Paris, France

The official event of the TINN2 FP7 European Research Project was organised by Inserm-Transfert on 8th October 2015 in Paris (France).

This meeting gathered together all TINN2 partners for presenting and discussing the latest progresses within TINN2 activities, a project on preclinical studies and paediatric investigation plans for children, under the coordination of the French National Institute of Health and Medical Research (Inserm).

European Congress of Clinical Microbiology and Infectious Diseases, London, United Kingdom 31st to 4th April 2012

 

TINN2 Project was presented on Poster at the ECCMID congress in London, United Kingdom.

Brochure PDF :

Context

In contrast to the situation in adults, most medicines used to treat the children of Europe have not been tested and are not authorised for use in children: the health and therefore quality of life of the children of Europe may suffer from a lack of testing and authorisation of medicines for their use.

In particular, 46% medicines prescribed to children in hospital are either unlicensed for their age group or, if licensed, are prescribed off label. Of the children who receive at least one medication in hospital, 67% receive an unlicensed or off-label drug, and in the context of intensive care, this rises to up to 90% of patients. There are major practical and ethical issues in relation to studying medicines in children, especially in the vulnerable group of preterm and term neonates.

A new Paediatric Regulation entered into force in early 2007 ensuring that medicines for use in children are of high quality, ethically evaluated and authorised appropriately. The Paediatric-Use Marketing Authorisation (PUMA) is a new type of marketing authorisation for drugs not covered by a patent, already available on the market for adults, but without information and/or formulation appropriate for children of all ages. The European Medicines Agency (EMA) has identified certain drugs as priority medicinal products for evaluation in the paediatric population. The trials that need to be carried out include pre-clinical studies since possible irreversible adverse effects on child development cannot be adequately or ethically assessed in paediatric clinical trials. Moreover, the Paediatric Regulation establishes measures to improve information on paediatric medicines.

Product information will include information from efficacy and safety studies conducted in children, including negative studies. Results of paediatric clinical trials performed both inside and outside the European Union (EU) will be published in the EU clinical trials database (EudraCT).