LENA
LENA
LENA

Medizinische Universität Wien

 

Medical University of Vienna 

 

Spitalgasse 23

1090 Vienna

Austria

 

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 Christoph Male

Principal Investigator 

Paediatric Cardiologist  

Associate Professor of Paediatrics and deputy chair for research in the Division of Paediatric Cardiology at the Medizinische Universität Wien (MUW) 

Expertise: paediatric cardiology, haemostasis and thrombosis, clinical pharmacology, drug evaluation and clinical trial methodology in children 

 

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Prof. Dr. Christoph Male, MD, MSc         

 

Christoph Male has received clinical training  in  paediatrics,  paediatric  cardiology,  and  paediatric  intensive  care.  At  McMaster University, Canada, he was trained in Health Research Methodology.

Since  2007, he  has  been  the  Austrian delegate to the PDCO at the EMA, and is currently chair of the extrapolation working group at the EMA. Dr. Male chairs the working group on drugs of the undefinedAustrian Paediatric Society, is the deputy executive officer of undefinedO.K.ids, and is the course director of the MSc Programme in Clinical Research at the MUW. He is also a member of the ethics committee and co-chair of the Paediatric Subcommittee of the International Society of undefinedThrombosis & Haemostasis (ISTH), and a board member of the Society of Thrombosis & Haemostasis Research (GTH).

The LENA Team in Vienna

 

Andreas Hanslik

Dr. Andreas Hanslik, MD

 

Co-Investigator

He completed his clinical training in paediatrics in 2010, and is currently undergoing training in paediatric cardiology. His areas of expertise include paediatric cardiology, and vascular and cardiac imaging methods. He is currently involved in research projects on the PK/PD relationship of heparin in children, and on imaging methods for diagnosis of thrombosis in patients with Fontan shunts.

 

 

Eva Wissmann

Eva Wissmann, RN

 

Research Nurse

She holds a diploma in paediatric nursing, and gained practical nursing experience from 1987 to 1992. Since 1992, she has been a research nurse in the Department of Paediatrics and has gained research experience in a broad range of clinical areas. She has been working for the Division of Paediatric Cardiology since 2001, with a focus on drug trials, including PK/PD studies. She has undertaken training courses for study nurses and is familiar with GCP guidelines.

 

About Us

The Department of Paediatrics at the Medizinische Universität Wien is a tertiary care university hospital encompassing all paediatric sub-specialities. The Medizinische Universität Wien has 5 clinical research divisions and 4 basic research units with a large portfolio in clinical research, and has been involved in more than 60 phase I-IV drug trials over the last 5 years. There is close cooperation with the Department of Clinical Pharmacology at the Medizinische Universität Wien on several projects in paediatric clinical pharmacology. Drug research projects receive administrative support from the Coordination Centre for Clinical studies at the Medizinische Universität Wien.

 

The Department of Paediatrics is a member of the recently built Austrian paediatric research network for drug studies (O.K.ids), which is designed to become part of the European paediatric network (EnprEMA).

 

The Division of Paediatric Cardiology is a referral centre for congenital and acquired heart disease, caring for an average of 1000 inpatients and 6000 outpatients, and performing 400 cardiac catheterizations and more than 200 heart operations in children per year. It is fully equipped with all state-of-the-art diagnostic and therapeutic facilities. The Division has a dedicated clinical research team with long- standing experience in drug trials, including PK/PD studies in children, and follows all SOPs for clinical research projects while remaining current with knowledge of GCP guidelines. The team has recently completed a randomized controlled trial (RCT) to establish the optimal heparin dose for cardiac catheterisation in children (see Hanslik et al., 2011). The team currently participates in several international academic and industry-sponsored drug trials.

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