The University Hospital Erlangen, Germany (Universitätsklinikum Erlangen – UKER) is the academic research and teaching Hospital of the Friedrich-Alexander University Erlangen –Nuremberg (FAU). FAU is one of Germany’s largest universities. The main focus in research and teaching is to be found at the interface between Natural Sciences, Engineering and Medicine. The University Hospitals consists of 24 clinics with approximately 1300 beds. The Department of Pediatric and Adolescent Medicine has 120 beds, of which 14 are situated in the Paediatric Intensive Care unit, 30 beds are located in the Department of Neonatology and 16 beds are to be found in the Neonatal Intensive Care Unit.
The Department of Paediatric and Adolescents Medicine has a longstanding experience in the conduct of paediatric clinical trials. It has its own clinical trial centre where currently about 20 trials (phase II- IV) (both from industry and academia) are administrated.
The group at the Department of Neuropaediatrics is well known for its scientific focus on neonatal neurology and neuroprotection and is also highly experienced in standardized clinical and neurophysiologic evaluation of neurodevelopmental outcomes in young children as well as in clinical studies according to GCP standards (phase IV studies, anticonvulsive drugs). Since 2007 research work has been supported by grants from the German Research Foundation (DFG, to Prof. Trollmann). All research staff at UKER has a recent training certificate in GCP.
UKER will participate as recruiting clinical centre in both GABA-1 (WP7) and GABA-2 (WP8) clinical trials. In addition to this, UKER will contribute to all the commonly shared activities of the GAPP project.
Regina Trollmann (MD, PhD) is Full Professor for Paediatrics and Neuropediatrics and Head of the Unit of Neuropediatrics at the Department of Paediatric and Adolescent Medicine. She is specialized in Paediatrics and Neuropediatrics. Prof. Trollmann has been the leader of the working group “Neonatal Neurology and Neuroprotection” of the European Paediatric Neurology Society (EPNS) since 2008. Prof. Trollmann’s group was awarded the ERCPN Research prize at the European Research Conference on Pediatric Neurology in 2010.
Antje Neubert (BPharm, PhD, MRPharmS) is Associate Professor and Head of the local Paediatric Clinical Study Centre. Before joining UKER in 2011 Dr. Neubert worked for 5 years at the School of Pharmacy, University of London where she was responsible for coordinating the UK activities of the EU-FP6 project TEDDY. She has long experience in paediatric clinical trials and currently coordinating the EU funded FP7 project CloSed.
Wolfgang Rascher (MD, PhD) is Professor of Paediatrics and Clinical Pharmacology and Head and Chairman of the Department of Pediatrics and Adolescent Medicine. He specializes in neonatology and paediatric nephrology. Prof. Rascher has been a member of the ad hoc Expert Group on Paediatrics (PEG), which advised the Committee for Medicinal Products for Human Use (CHMP) on specific expertise until it was replaced by the Paediatric Committee in 2007. Prof. Rascher is the Chairman of the Committee for Children and Adolescents at the Federal Institute for Drugs and Medical Devices, the German federal authority for licensing and registering of Medicinal Products. He is member of the ‘Arzneimittelkommission der Deutschen Ärzteschaft’ and of Ethics Committee at the ‘Bayerische Landesärztekammer’. Wolfgang Rascher has over 400 publications in scientific journals.
Stefan Wimmer (RPh) is PhD student and supports the Paediatric Clinical Study Centre concerning regulatory activities, drug supply and storage.