CORE-MD WEBINARS​

The CORE-MD consortium organises webinars to present the outcome of the work performed by partners.

Webinar October 2023

The clinical evaluation of artificial intelligence and standalone software: keeping the balance between benefit and risk.

Tuesday 17 October 2023 | 17:00 – 18:15 CET | Online Registration available soon

Webinars November 2023

What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Results and implications of the CORE-MD systematic reviews

Monday 6 November 2023 | 17:00 – 18:15 CET | Online Registration available soon

International standards for clinical investigations of high-risk medical devices – the CORE-MD analysis with recommendations to regulators.

Monday 20 November 2023 | 17:00 – 18:15 CET | Online Registration available soon

Webinar December 2023

IT tools for regulatory science: aggregating available data for assisting Expert Panels and improving post-market surveillance.

Monday 5 December 2023 | 17:00 – 18:15 CET | Online Registration available soon

Webinar January 2024

Early clinical investigations of new high-risk medical devices – a review of European experience.

Monday 8 January 2024 | 17:00 – 18:15 CET | Online Registration available soon

Available Online Webinar REPLAY

Training and Education for Regulators, Notified Bodies, and Clinicians. 

Monday 10 July 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

On Monday 10th of July, the CORE-MD consortium organised its forth webinar on training and education. 

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 presentation of Claudia Wild and Sabine Ettinger from AIHTA is available here

The presentation of Tom Melvin from Trinity College Dublin is available here

The presentation of Kenneth J. Cavanaugh and Stephanie Shedd from FDA is available here

The presentation of Esther Martinez from European Medicines Agency is available here

The presentation of Elizabeth Macintyre from Biomed Alliance is available here

Objective Performance criteria for medical devices – origins, methods, and clinical utility

Monday 3 April 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

On Monday 3rd April 2023 from 17.00 until 18:15 (CET), the CORE-MD consortium organised its third webinar on objective performance criteria (OPC).

Moderated by Prof. Alan Fraser, from the European Society of Cardiology, and Prof. Ewout Steyerberg, from Leiden University, the webinar addressed the issue of the origins, the methods and the clinical utility of objective performance criteria. In his introductory words, Prof. Steyerberg outlined the longstanding experience of Prof. Krunkemeier with respect to OPCs.

Prof. Gary Krunkemeier from the Oregon Health and Science University (USA) presented the origins of objective performance criteria in cardiac devices.

Prof. Robert Byrne, from the Dublin Hospital and Royal College of Surgeons of Ireland, presented the evaluation of coronary stents.

The Origins and Objectives of European Regulations for Medical Devices

Monday 6 March 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

On 6th March 2023, the CORE-MD consortium organised a webinar on the origins and the objectives of the Medical Device Regulation (Alan Fraser). The webinar also addressed the issue of regulatory science (Tom Melvin). Prof. Rob Nelissen presented the role of the expert panels while Dr Paul Piscoi highlighted the role of clinicians from the European Commission’s perspective.

The presentation of Prof. Alan Fraser is available here

The presentation of Ass. Prof. Tom Melvin is available here

The presentation of Dr Paul Piscoi is available here

Orthopaedic Implants and European Medical Device Regulations

Monday 6 March 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

On 30th January, the CORE-MD consortium organised a webinar on Orthopaedic Implants and Medical Device Regulation.

The presentation of Prof. Anne Lübbeke-Wolff is available here

The presentation of Dr Keith Tucker is available here