Leader: Giuditta Callea (SDA Bocconi)
Co-leader: Marta Kerstan (DePuy Synthes)
Leader: Tom Melvin (Trinity College Dublin)
Co-leader: Nicolas Martelli (Assistance Publique – Hôspitaux de Paris)
Leader: Alexandra Poulsson (Norwegian Institute of Public Health)
Co-leader: Nataliya Deych (Edwards Lifesciences Europe)
Co-leader: Carlo Federici (SDA Bocconi)
Leader: Monica Tocchi (Meditrial Srl)
Co-leader: Alessandra Denaro (Abbott)
Co-leader: Keshav Kohli (Abbott)
Leader: Giuditta Callea (SDA Bocconi)
Leader: Rosanna Tarricone (SDA Bocconi)
Leader: Francesco Malandrini (SDA Bocconi)
Co-leader: Antonio Balsamo (Agenas)
Co-leader: Gabriella Di Santo (Agenas)
Co-leader: Alessandra Lo Scalzo (Agenas)
Co-leader: Marco Marchetti (Agenas)
This section includes ten training videos developed for stakeholders participating in the HEU‑EFS pilot process. The videos outline the key elements of the HEU‑EFS framework that stakeholders will follow throughout the pilot, including key definitions for EFS, eligibility criteria, requirements for clinical sites and investigators, stakeholder roles, overviews of templates and checklists for the clinical investigation plan, informed consent form, master clinical trial agreement and insurance agreement, strategies for patient involvement, and a complete description of the pilot process.
Definitions of EFS and low- vs high-risk medical device
Presenter: Maria Luisa Buzelli (UB)
Description of the eligibility criteria for medical device technologies, patient population, and level of preclinical evidence to participate in the HEU‑EFS pilot
Presenter: Kevin Drisko (Edwards Lifesciences)
Overview of requirements for clinical sites to participate in the HEU-EFS pilot, such as those related to regulatory competency, good clinical practices, equipment, and clinical staff experience
Presenter: Nicolas Martelli (APHA)
Overview of the elements of the HEU-EFS framework, including Contact Point, Early Dialogue, Submission, Validation, and Review
Presenter: Alexandra Herborg Cornelius Poulsson (NIPH)
Description of responsibilities of key actors (i.e., sponsor, CRO, regulatory authority, EC, investigational site, Principal Investigator) involved in the HEU-EFS pitot process
Presenter: Tom Melvin (Galway)
Description of development and content of Clinical Investigation Plan template and checklist
Presenter: Monica Tocchi (Meditrial)
Description of supporting documents (i.e., Informed Consent Form, Master Clinical Trial Agreement and Insurance Agreement) during the HEU‑EFS pilot process
Presenter: Francesco Malandrini (UB)
Description of the approach used to collect data required to calculate Key Performance Indicators (KPIs) of HEU-EFS pilots
Presenter: Federico Facciolo (UB)
Description of patient involvement strategies to be used before, during, and after the EFS
Presenter: Yasemin Zeisl (EPF)
Description of the key process steps of the HEU-EFS pilot process, including Expression of Interest, Information Call, Online Form, Prioritization, Training on HEU-EFS, and application to NCA
Presenter: Giuditta Callea (UB), Manon Gielkens (Medtronic), Fanny van der Loo (Edwards Lifesciences)