Regulatory Affairs and Clinical Trials for Children

In national and European medical device legislation, the pediatric aspects have so far been absent or neglected. Also in view of the currently changing medical device legislation (MDR) and the associated difficulties for pediatric medical devices, our congress series PedMedDev provides for the first time the necessary forum for regulatory affairs for children. Since 2016, it has established itself as a platform involving all stakeholders.

With regard to clinical trials for children, current topics such as computational modeling and simulation in clinical trials and real world data/evidence will be presented and discussed with you by leading experts.

Chairs:
Prof. Dr. Heike Wachenhausen | Technische Hochschule Lübeck, Lübeck, Germany
Dr. Ludger Tüshaus | Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany

• www.symposium.pedmeddev.org/program/day-1