ISPOR Europe 2024

[17-20 November 2024 | Barcelona, Spain] Representing the HEU-EFS project, partners from SDA Bocconi and Trinity College Dublin will present a series of poster sessions.

Subject of Debate

Innovative, high-risk medical devices can revolutionize treatment but often require numerous modifications before arriving at a final design. Addressing both the important risks and significant benefits for patients, research centres, regulatory bodies, and sponsors is crucial. The main objective of the 4-year HEU-EFS Project, funded by the Innovation Health Initiative and involving 22 public and private partners, is to develop a harmonized methodology for the uptake of Early Feasibility Studies (EFS) in the EU that mitigates risks and reinforces benefits for various stakeholders.

Poster Sessions and Presenters:

• Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR67
  Speaker: Francesco Malandrini from SDA Bocconi
• Use of Early Feasibility Studies to Inform Development of Medical Devices
  Session Time: 20 November 9:00 AM – 11:30 AM – MT58
  Speakers: Franco Luigi Zurlo from SDA Bocconi
• The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR98
  Speaker: Majella Geraghty from Trinity College Dublin

Who Should Attend:

These poster sessions can provide valuable insights for a diverse group of stakeholders, including EU-wide and national regulators, competent authorities, notified bodies, HTA bodies, healthcare providers, patient organizations, research organizations, legal and ethical experts, CROs, and health technology developers.