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.

To learn more about the HEU-EFS’s progress and outcomes, follow us on LinkedIn and X.