On Monday 10th of July 2023, the CORE-MD consortium organised its forth webinar on training and education. The REPLAY is now available.
Moderated by Claudia Wild from AIHTA, the learning objectives of the webinar are:
- To present the results of the survey on perceptions of regulators, notified bodies and clinicians on Education and Training needs – performed by the CORE-MD partners.
- To reflect the perceived needs and to look into existing and future European and US-American initiatives to improve Training and Education of Regulators, Notified Bodies and Clinicians.
The aim of the CORE_MD activities is to identify the needs for advanced training for the assessment of high-risk medical devices, in the context of the EU Medical Device Regulation (MDR).
The outcome of the research is a Roadmap (available soon) for education & training – Notified Bodies, Regulators, Clinicians, which includes:
•Overview of literature regarding “regulatory science and regulatory affairs”
•Landscape of available advanced trainings, qualifications related to MDR
•Exploratory interviews with stakeholders (notified bodies, clinicians, regulators)
•Online survey to stakeholders. Content: 25 questions, ~ 15 min, perceived needs for training in regulatory affairs, core methodological competencies as well as view on training formats and modalities.
The online survey was launched in summer 2022, and it collected the perceived needs for training in regulatory sciences and in core methodological competencies as well as the views of the respondents on training formats and modalities. The results of the survey were then discussed within the CORE-MD consortium and used to lay the basis for the recommendations. The survey asked respondents to estimate their need for education in core competencies that were structured into six domains. Three of these (Clinical investigation, Legal/regulatory requirements for market access, and Post-market surveillance) listed detailed skills.
Survey results:
This survey identified both real gaps (defined by critical skills needed by a stakeholder to do their job correctly), and ‘ideal’ needs (defined by additional nice-to-have skills). The real gaps identified for each stakeholder group are as follows:
Visit our webinar web page to see the upcoming webinars and to download the presentations of the panelists.
