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

An agency of the European Union

Endorsem ent of new or updated applications for Enpr- EMA m em bership

Presented by: Benjamin Pelle Enpr-EMA CG meeting, 27 June 2014

1

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

2

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