ISSUE: Nowadays, in the EU there are no standardized procedural frameworks for the uptake of EFS. This hinders the application of the lifecycle approach for clinical evidence generation of MDs envisaged by EU Regulations (MDR, IVDR, HTAR), slows down European patients’ access to innovation, and EU competitiveness. The HEU-EFS Project is a 4 year project funded by the Innovation Health Initiative and 6 industry partners, which aims at addressing these challenges by developing a harmonised methodology for the uptake of EFS in the EU.

OVERVIEW:

Prof. Callea (15 minutes) will present the HEU-EFS Project rationale and objectives, and will discuss with panelists the potentials of the future EU EFS Program.

Prof. Melvin (10 minutes) will discuss the relevance of the EU EFS Program for the public entities involved in the assessment of medical technologies and the expected impact on the current regulatory framework as well as on the clinical evidence-generation process in the EU.

Prof. Kidholm (10 minutes) will present the advantages and challenges perceived by public teaching hospitals regarding the establishment of an EU-EFS Program.

Mr. Rappagliosi (10 minutes) will discuss the expectations of developers of breakthrough technologies, also given previous experience in the conduction of EFS in the USA. He will explain the importance for companies to access a clear framework to uptake EFS in the EU and the importance of public-private collaboration for its development.

In the last 15 minutes, Prof. Callea will collect questions from the audience to be discussed with panelists in a round table.

A number of stakeholders will benefit from attending the panel session 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.