PO-0930 Enpr-ema, A Platform For Disseminating Good Practices About Paediatric Medicines Research Across Europe And With International Partners

Abstract

Background and aims The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) was set up in accordance with Article 44 of the Paediatric Regulation 1 . Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in the paediatric population with the mission of facilitating studies in order to increase the availability of medicinal products authorised for use in the paediatric population 2 . Methods To register with Enpr-EMA, networks must fulfil the requirements laid down by a set of six recognition criteria for quality of paediatric research (Figure 1). Enpr-EMA Working Groups have recently been established (Table 1) to address important issues. Results There are currently 38 registered networks or centres 3 (Table 2). Past work includes supporting the development of 3 new networks; disseminating good practice relating to the involvement of children and young people in research. Ongoing work includes: sharing good practice within Enpr-EMA and Industry Partners; developing a check list of Ethics Committee submission documents; a roadmap to lobby the European Commission about the need to support medicines development in children; establishing a joint PDCO/Enpr-EMA Working Group on neonatology; initiating collaboration with paediatric networks in the USA. Conclusions After successful implementation of Enpr-EMA as a platform for sharing good practices among paediatric clinical trials networks 4 , Enpr-EMA is addressing some important hurdles to the development of medicines for children. Enpr-EMA invites paediatric centres/investigators to contribute to its work and/or become a member. Acknowledgments Not applicable. References 1 Regulation (EC) No 1901/2006 of the European Parliament and the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation EEC No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 2 Ruperto et al . A European network of paediatric research at the European Medicines Agency (Enpr-EMA). Arch Dis Child 2012;97(3):185–8 3 Enpr-EMA webpages: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000303.jsp and mid=WC0b01ac05801df74a 4 5-year report to the European Commission. General report on experience acquired as a result of the application of the Paedi-atric Regulation, prepared by the European Medicines Agency with its Paediatric Committee: http://ec.europa.eu/health/files/paediatrics/2013_com443/paediatric_report-com (2013)443_en.pdf