Indicative schedule :

18:00 – 18:05 Introduction by Moderator Prof. Alan Fraser, Cardiff University, CORE-MD Scientific Coordinator.
18:05 – 18:15 Systematic Review of evidence for high-risk medical devices in Children | Kathrin Guerlich. Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children’s Hospital, Munich, Germany.
18:15 – 18:25 Disappearing Orphan Devices | Em. Prof. Marc Gewillig, Association of European Paediatric Cardiology
18:25 – 18:35 Special Regulatory Pathway for orphan products | Dr Rachel Neubrander, Branch Chief, Structural Heart Devices Branch at FDA
18:35-18:45 CORE-MD recommendation on medical devices in children | Prof Berthold Koletzko, European Academy of Paediatric
18:45 – 19:15 Question and Answers with the audience

Learning objectives :

  • To understand the challenges of availabilities of medical devices for children.
  • To receive recommendation from CORE-MD on how to improve availability of medical devices for children.
  • To receive other regulator’s views on approval of medical devices for children.