3rd International Symposium on Pediatric Medical Devices

Regulatory Affairs and Clinical Trials for Children

Day 1 | February 9, 2021

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

CETESTTitle   
15:0009:00 AMOpening   
Scientific Session 1
15:0509:05 AMEvaluation of the Paediatric Regulation: how the current framework can be improved
Dr. Fabio D'Atri | European Commission, Bruxelles, Belgium
   
15:3009:30 AMIncreasing safety in children using the example of drug therapy
Prof. Dr. Antje Neubert | Universitätsklinikum Erlangen, Erlangen, Germany
   
15:5509:55 AMProving the effectiveness of pediatric medical devices
Prof. Dr. Stefan Sauerland | Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Köln, Germany
This talk first examines where effectiveness data are required for new pediatric medical devices. After CE marking, most medical devices are reimbursable in German healthcare without any need for effectiveness data. In the second part, the challenges of performing clinical studies on (pediatric) medical devices are discussed. The typical problems, e.g. impossibility of blinding, presence of learning curves, and incremental device modifications, can all be solved. Therefore, randomized controlled trials on new pediatric medical devices should be considered the standard option, unless the expected treatment effects are large and thus clearly detectable in observational studies.
   
16:2010:20 AMClosing Discussion
All Speakers of Session 1
   
16:3010:30 AMBreak   
Scientific Session 2
16:4010:40 AMNew frontiers in regulatory affairs using the example of closed loop systems in pediatric diabetology
Prof. Dr. Thomas Danne | Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany
   
17:0511:05 AMHow to get from clinical data to clinical evaluation for pediatric medical devices
Prof. Dr. Michael Imhoff | Ruhr-University Bochum; Clinical Director, qtec group
Among many other things the Medical Device Regulation (MDR; (EU)2017/745) requires a clinical evaluation as part of the conformity assessment for every medical device. This clinical evaluation provides evidence of the safety, performance and benefit of a medical device based on clinical data. For pediatric medical devices gathering sufficient clinical data is a formidable task, because compared to adult populations, pediatric patient populations are much smaller, more often affected by rare diseases, represent vulnerable populations, and many relevant medical devices are not approved for pediatric use. Unfortunately, the MDR does not adequately consider the specific challenges of pediatric patient population with respect to the requirements for clinical data.
   
17:3011:30 AMConcepts to overcome hurdles of innovation and development of pediatric medical devices
Prof. Dr. Thomas Lenarz | Medizinische Hochschule Hannover, Hannover, Germany
   
17:5511:55 AMClosing Discussion
All Speakers of Session 2
   
18:0512:05 AMBreak   
Scientific Session 3
18:1512:15 AMThe power of computational modeling for clinical trials and regulatory processes
Dr. Marc Horner | ANSYS, Canonsburg, PA, USA
Computational modeling and simulation (CM&S) has the potential to revolutionize medical device development by accelerating innovation and providing comprehensive long-term safety evidence.  The vision is that CM&S results will join bench, animal, and human testing as an essential element of device approvals.  However, the credibility of a computational model must be established before using CM&S results for decision-making.  ASME, US FDA, and others are developing standards and guidance focused on CM&S credibility and reporting to support regulatory evaluation.  This presentation will provide an overview of the regulatory opportunities and discuss current challenges.
   
18:4012:40 AMUsing real-world evidence (RWE) to enhance regulatory and clinical trials
Prof. Dr. Art Sedrakyan | Weill Cornell Medicine, Cornell University, New York, USA
   
19:0501:05 PMClosing Discussion
All Speakers of Session 3
   
19:2001:20 PMWrap up and Closing   

Supporting Institutions

Sponsors

Die Durchführung der Veranstaltung wird durch eine Zuwendung der B. Braun-Stiftung ermöglicht.