Annual Consortium Meeting in Geneva
[7-8 October 2024, Geneva] – The HEU-EFS Consortium gathered for our annual consortium meeting, marking a significant milestone in our journey towards harmonizing Early Feasibility Studies (EFS) across Europe.
Meeting Recap:
- Research and analysis on the state of play of premarket programs and implementation barriers to EFS (WP1) & regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
- The initial results of the research-focused work packages have been shared and discussed with the HEU-EFS advisory bodies, including the Patient Advisory Group and the Advisory Board. Their feedback is crucial to ensure that both WP1 and WP2 provide a solid foundation for methodology development activities.
- In reviewing the premarket programs, the University of Bocconi has designed a survey for MedTech innovators, including companies, SMEs, and start-ups involved in medical device development and clinical investigations. The survey aims to gather their experiences and challenges in pre-market clinical investigations. Take the survey here.
- Click here to watch what WP1 and WP2 are focusing on, as described by our Work Package leaders.
- Research and analysis on the regulatory framework and institutional and organizational characteristics of EU competent authorities (WP2)
- Engaged in interactive sessions with the Patient Advisory Group (PAG) and Advisory Board (AB) to gather valuable feedback.
- Methodology development: evidence requirements, data, and statistical tools (WP3)
- The orchestration of methodology development activities is now the primary focus of the HEU-EFS project. To establish a widely accepted framework, HEU-EFS ensures the inclusion of all key stakeholders in the methodology development process.
The collaboration and expertise of our consortium members were on full display as we worked together to address the challenges and opportunities within the EFS ecosystem. We are excited to share that our collective efforts are paving the way for a more efficient and effective European Health System.
Stay tuned for more updates as we continue to break new ground in healthcare research and patient care.