European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice

    Description

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EPLTN - European Paediatric Liver Transplantation Network

Number of peer reviewed publications in the last 5 years 1189
Number of competitive grants obtained in the last 5 years 2 Due to the very recent formation of the network, no pulications as yet reflect the work of the whole network. All centres have published their respective research in peer-reviewed publications; publication lists are enclosed.
Access to expert groups Yes Network participants are active members and have access to a number of paediatric expert groups, including: European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), British Society for Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN), European Association for the study of the Liver (EASL), German Society for Paediatric Gastroenterology, Hepatology and Nutrition (GPGE), Swiss Society for Paediatric Gastroenterology, Hepatology and Nutrition (SGPGHE), French Society for Paediatric Gastroenterology, Hepatology and Nutrition (GFHGNP), Polish Society for Paediatric Gastroenterology, Hepatology and Nutrition (PSPGHAN), Spanish Society of Gastroenterology, Hepatology and Paediatrics Nutrition (SEGHNP), Italian society of paediatric gastroenterology and hepatology SIGEP)
Capacity to answer external scientific questions Yes 1. Membership in international scientific societies: a. ESPGHAN: U. Baumann COMMITTEE ON HEPATOLOGY, Chairman b. IPTA c. EASL d. AASLD 2. Scientific advisory committee of pharmaceutical companies: Astellas Novartis Albireo Orphan Europe
Site feasibility Yes Standard operating procedures to define required criteria for study participation have been developed for the current study. These will need to be adapted according to specific study-related requirements for future network-based research projects.
Participant recruitment Yes All participating sites have ample experience in recruiting participants for clinical trials. Progress of recruitment for the current study will be monitored on the occasion of regular network meetings.
Budget calculation for studies Yes Budget calculation is incorporated into grant applications and study design. It will be provided by the site initiating a given study, and counter-checked by the other participating centres.