CORE-MD WEBINARS​

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

Webinar February 2024

Monitoring Life Cycle of an implant in Real Life

Monday 19 February 2024 | 17:00 – 18:15 CET | OPEN REGISTRATION

Registries are providing significant amount of information on medical devices, especially in Orthopaedics. Within the CORE-MD Consortium research has been undertaken to explore the possible benefit of registry-based data as real-world evidence for the postmarket surveillance of medical devices. 

The webinar will notably capitalise on the work done by Perla Marang Van de Mheen from Delft University and provide insights on the use of registry data for regulatory purposes. Together with colleagues from regulators, healthcare professionals and notified bodies, they will discuss how to use registries as evidence for the evaluation of medical devices.

The Webinar will address the following topics:
 
17:00-17:05 Introduction by ModeratorDr Tom Melvin, Trinity College Dublin
 
17:05 – 17:25 Assessing the performance and safety of medical devices using registry data | Dr Perla J. Marang-van de Mheen, PhD, Associate professor Quality & Safety of Care , Delft University of Technology
 
17:25 – 17:35 Use of real-world data for approval and particularly on conditional certification | Richard Holborow, Global Head of Clinical Compliance at BSI
 
17:35 – 17:45 How do they select a good implant, what is the role of registries in assessing potential safety risks: a professionnal’s perspective | Prof. Rob Nelissen, Leiden Medical University Center, Secretary General of EFORT
 
17:45-17:55 – Manufacturers perspective needs and challenges pertaining to registry data | Dr Joshua Bridgens, Depuy Synthes 

17:55 – 18:15 – Question and Answers with the audience

Learning objectives :

  • Discover the activities performed during the CORE-MD project analysing validity of registry data for regulatory purposes
  • Understand regulators needs in  post-market surveillance and vigilance
  • Receive viewpoints from practising physicians and notified bodies on the possible use of registries for regulatory purposes.

Webinar March 2024

Patient Reported Outcome Measures

Monday 4 March 2024 | 17:00 – 18:15 CET | OPEN REGISTRATION

It is often said that PROMS offer valuable information to improve the quality of care. The CORE-MD Consortium has undertaken a research to evaluate the potential utility of PROMS in the clinical evaluation and investigation process as well as in the postmarket surveillance phase. Dr Ola Rolfson and John Chaplin from Gotenburg University have led the study and will present their findings and recommendation during this webinar.

*By registering to the webinar, you will automatically be registered to the Newsletter. 
Should you wish to be removed from the CORE-MD distribution list, please send an email to eu [a] efort.org

Available Online Webinars - REPLAYS

Monday 8 January 2024 | 17:00 – 18:15 CET | REPLAY AVAILABLE

Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation

The CORE-MD consortium organised its tenth webinar on “Early clinical investigations of new high-risk medical devices – how lack of transparency inhibits improvement in evaluation” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.

Learning Objectives:

  • To understand the challenges of early clinical investigation in the context of the medical device regulation.
  • To receive viewpoints and perspectives from Patients, Manufacturers and Regulators.
  • To explore possible solutions stemming from CORE-MD recommendation.

 

The presentation of Prof. Peter McCulloch is available here.

The presentation of Prof. Mark Slack is available here.

The presentation of Ms Claudia Louati is available here.

Providing high-risk medical devices for children – problems and proposals

Thursday 14 December 2023 | 18:00 – 19:15 CET | REPLAY AVAILABLE

The CORE-MD consortium organised its ninth webinar on “Providing high-risk medical devices for children – problems and proposals” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.

Learning Objectives:

  • To understand the challenges of availabilities of medical devices for children
  • To receive recommendation from CORE-MD on how to improve availability of medical devices for children
  • To receive other regulator’s views on approval of medical devices for children.

 

The presentation of Kathrin Guerlich is available here.

The presentation of Em. Prof. Mark Gewillig is available here.

The presentation of Prof Berthold Koletzko is available here.

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

Monday 05 December 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

The CORE-MD consortium organised its eighth webinar on “IT tools for regulatory science” moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.

Learning Objectives:

  • To discover the activities performed during the CORE-MD project in support to automated data
    aggregation of safety notices for post-market surveillance.
  • To understand EMA Expert Panel’s roles in post-market surveillance and vigilance.
  • To receive regulator’s perspective on the use of real-world evidence.

The presentation of Prof. Enrico Caiani is available here.

The presentation of Dr. Miguel Antunes is available here.

The presentation of Sanjeev Yoganathan is available here.

Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?”

Monday 27 November 2023 | 17:00 – 18:15 CET | REPLAY AVAILABLE

The CORE-MD consortium organised its seventh webinar on Pivotal Clinical Investigations of High-Risk Medical Devices moderated by Prof. Alan Fraser, BioMed Alliance, Scientific Coordinator of CORE-MD.

Learning Objectives:

  • To become familiar with the existing recommendations on Trial Designs of pivotal clinical investigation for medical devices.
  • To explore notified bodies’ needs and expectations, in the context of the implementation of the MDR.
  • To understand the role of EU regulators with respect to clinical investigations in the EU.
  • To interact with key players in the field of clinical evaluation of high-risk medical devices.

The presentation of Dr. Petra Schnell-Inderst is available here.

The presentation of Richard Holborow is available here.

The presentation of Gearóid McGauran is available here.

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 | REPLAY AVAILABLE

The CORE-MD consortium organised its sixth webinar on high-risk medical devices in the field of cardiovascular disease and diabetes moderated by Prof. Robert Byrne, Director of Cardiology and Director of the Cardiovascular Research Institute at Mater Private Network, Dublin, Ireland.

Learning Objectives:

  • Quality and transparency of clinical evidence for high-risk cardiovascular medical devices.
  • Quality and transparency of clinical evidence for high-risk diabetic medical devices.

 

The presentation of PD Dr. Georgios Siontis is available here.

The presentation of PD Dr. Arjola Bano is available here.

The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance between benefit and risk.

Tuesday 17 October 2023 | 17:00 – 18:30 CET  | REPLAY AVAILABLE 

The CORE-MD consortium organised its fifth webinar on Artificial Intelligence moderated by Em. Prof. Frank Rademarkers, CORE-MD Task leader.

The learning objectives of the webinar are:

  • Understand the regulatory aspects of AI in the healthcare setting.

  • Receive the recommendation on clinical evaluation of AI from CORE-MD

  • Explore current challenges in AI in a medical discipline.

  • Understand Ethical aspects of AI in a  healthcare setting.

The presentation of Prof. Frank Rademakers is available here.

The presentation of Dr. Eva Van Steijvoort is available here.

The presentation of Dr.Claudius B Griesinger is available here.

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 30 January 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

*By registering to the webinar, you will automatically be registered to the Newsletter. Should you wish to be removed from the CORE-MD distribution list, please send an email to eu [a] efort.org