Presented by: Benjamin Pelle Enpr-EMA CG meeting, 27 June 2014 An - PowerPoint PPT Presentation

Endorsem ent of new or updated applications for Enpr- EMA m em bership Presented by: Benjamin Pelle Enpr-EMA CG meeting, 27 June 2014 An agency of the European Union

European Paediatric Liver Transplantation Netw ork ( EPLTN) Outline: new application • Coordinating site: Paediatric Hepatology and Gastroenterology, Hannover, DE Specialty network: specialist centres providing clinical care and research for children with liver disease and liver transplantation Aim: clinical and translational research, and definition of clinical guidelines 7 collaborative centres: Germany, France, Spain, Italy, Switzerland, Poland, UK Paediatric age range: 0-18 years Proposed Category Num ber: • Evidence to be provided on network organisation, SOPs, quality, adherence to GCP and public engagement Network website under construction  CATEGORY 3 1

Réseau d'I nvestigation Pédiatrique des Produits de Santé ( RI PPS) Outline: updated application • Currently: Enpr-EMA category 3 network Coordinating sites: Saint Vincent de Paul-Cochin, Paris, FR and CIC, Lyon, FR National network: Neurodevelopmental disorders (drug and device trials) 5 collaborative centres in France Paediatric age range: 0-18 years • Proposed Category Num ber: Clarifications to be provided on details of primary site coordinator No public engagement in research SOPs/ evidence of claims available but network website under construction  CATEGORY 3 2