Christoph Male, MD, MSc, is consultant and associate professor at the Department of Pediatrics, Division of Pediatric Cardiology, Medical University of Vienna (MUV), Austria, where he heads the pediatric hemostasis & thrombosis unit, acts as deputy-chair for research, and leads the paediatric clinical research unit.
He trained in general medicine and pediatrics, with subspeciality degrees in pediatric cardiology and pediatric intensive care. He did a clinical and research fellowship with the Paediatric Thrombophilia Programme at the Hospital for Sick Children, Toronto, and McMaster University, Hamilton, Ontario, Canada, where he also earned a M.Sc. degree in Health Research Methodology. He completed several courses in hemostasis and thrombosis research, on the ‘Evaluation of Medicinal Products in Children’, participated in workshops on modelling & simulation, and extrapolation at the European Medicines Agency (EMA), as well as ICH/GCP courses.
Dr. Male’s scientific interest is in pediatric hemostasis & thrombosis, anticoagulation, clinical pharmacology, drug evaluation and clinical trials methodology in children. He has long-standing experience in clinical research and has been involved as investigator and steering board member in multiple academic and industry-sponsored clinical trials in children.
He is former chair of the Pediatric Scientific and Standardization Subcommittee (SSC) of the International Society of Thrombosis & Hemostasis (ISTH), where he leads its Antithrombic trial working group. He was panel member for the Guideline on Pediatric Venous Thromboembolism by the American Society of Hematology (ASH) published in 2018. He is also member of the Association for European Paediatric and Congenital Cardiology (AEPC) Task Force on drug development. He is chair of the management board of the PedNet Haemophilia Foundation, chair of the scientific board of the Austrian Haemophilia Society, and past board member of the Society of Thrombosis and Haemostasis Research (GTH). He serves as expert for Connect4children (C4C) European collaborative network for clinical trials for children: i) cardiology expert group, ii) clinical trials & methodology expert group.
Dr. Male served as Austrian delegate in the Paediatric Committee (PDCO) at the European Medicines Agency from 2007-2016, where he chaired its extrapolation working group; he still serves expert for the EMA. He is member of the Scientific Board of the Austrian Medicines Agency, pediatric member of the ethics committee of the MUV. He is director of the Austrian Paediatric Formulary (Kindermedika.at). He was founding and board member of the Austrian Paediatric Research Network (OKIDS). He is past course director of the postgraduate curriculum in ‘Clinical Research’ at the MUW, and is continuously lecturing in various courses on study design.