Objectives of the CRT Meeting
This important event will explore possibilities for harmonisation of global medical device regulation, opportunities of priority access for health technology innovation and regulatory aspects of orphan devices. It is a follow-up meeting to a previous event on medical device regulation held in November 2022.
Related Reading
Session Recordings
Day 1
Session 1
Session 2
Day 2
Session 3
Breakout
Programme
Academic Chairpersons
- Prof. Alan Fraser
- Prof. Martine Gilard
- Prof. Thomas F. Lüscher (ESC President-elect and ESC Chair of the CRT)
- Prof. Piotr Szymanski
- Prof. Stephan Windecker
Industry Chairpersons
- Dr. Jennifer Franke (Philips)
- Dr. Jana Kurucova (Edwards Lifesciences)
- Prof. Eigil Samset (GE Healthcare)
- Dr. Alphons Vincent (Medtronic)
Day 1: 17 April 2024 13:00–18:40 CEST
| Time | Session | Speaker |
|---|---|---|
| 12:00-13:00 | Arrival and buffet lunch | |
| 13:00-13:05 | Welcome from the CRT Chairpersons | Thomas F. Lüscher |
| 13:05-13:15 | General introduction to the workshop |
Martine Gilard Stephan Windecker |
| 13:15-13:40 | A clinical academic perspective on the EU medical device regulatory system: how should it evolve? | Alan Fraser |
| 13:40-14:00 | European Commission review of the implementation of the medical device regulations - challenges and proposals | |
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14:00 -17:10 - SESSION 1 – Priority access for health technology innovation Moderated by: Stephan Windecker and Jana Kurucova (Edwards Lifesciences) |
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| 14:00-14:15 | Regulatory approaches to facilitating device innovation | Andrew Farb, FDA (via zoom) |
| 14:15-14:30 | Joint approval programme between the USA and Japan for innovative devices | Mitchell Krucoff |
| 14:30-14:45 | Panel discussion |
Piotr Szymanski Martine Gilard Changfu Wu, FDA (via zoom) |
| 14:45-15:00 | Coffee break | |
| 15:00-15:15 | Patient’s perspective on accelerated approval pathways | Inga Drossart (ESC Patient Forum) |
| 15:15-15:30 | Physician/innovator perspective on accelerated approval pathways | Stephan von Bardeleben |
| 15:30-15:45 | Industry perspective on the EU medical device regulatory system: how should it evolve? | Andrea Rapagliosi (Edwards) |
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15:45-16:30 - BREAKOUT SESSIONS 1 Moderated by: Piotr Szymanski and Jennifer Franke (Philips) |
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| Group 1: What can Europe and FDA learn from each other? |
Lead: Mitchell Krucoff Rapporteur: Mario Grabelli Cosellu |
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| Group 2: How to achieve predictable application of standards across EU notified bodies and expert panels | Lead: Radosław Parma Rapporteur: Marco Metra |
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| Group 3: How to achieve transparency of evidence and of regulatory reviews for medical devices in the EU | Lead: Alan Fraser Rapporteur: Lia Crotti |
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| 16:30-16:40 | Report from breakout session 1 – 10 mins | Rapporteur: Mario Grabelli Cosellu |
| 16:40-16:50 | Report from breakout session 2 – 10 mins | Rapporteur: Marco Metra |
| 16:50-17:00 | Report from breakout session 3 – 10 mins | Rapporteur: Lia Crotti |
| 17:00-18:25 |
SESSION 2 – Global harmonisation of device approval Moderated by: Thomas F. Lüscher and Eigil Samset (GE Healthcare) |
|
| 17:00-17:15 | Global convergence of regulatory standards | Bram Zuckerman, FDA (via zoom) |
| 17:15-17:30 | Global cardiovascular device market | John Brennan (Medtronic) |
| 17:30-17:45 | Global access to medical devices |
Leila Abid |
| 17:45-18:00 | International standards for medical devices – can they be produced and implemented globally? | Ajay J Kirtane |
| 18:00-18:15 | Total lifecycle assessment - new devices, post market surveillance, device iterations and recertification | Giulio Stefanini |
| 18:15-18:25 | Wrap-up and summary day 1 – Outlook to day 2 | Chairpersons |
| END OF DAY 1 | ||
| 19:45 | Dinner | |
Day 2: 18 April 2024 08:30–12:15 CEST
|
Time |
Session |
Speaker |
|---|---|---|
|
08:30-08:40 |
Summary of day 1 |
Stephan Windecker |
|
8:40-12:10 - SESSION 3 – Orphan devices and unmet medical needs Moderated by: Martine Gilard, Alphons Vincent (Medtronic) |
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08:45-09:00 |
Criteria for orphan device status - current proposals and definitions |
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09:00-09:15 |
Do proposed definitions meet the unmet needs of cardiologists and cardiac surgeons? |
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09:15-09:30 |
Evidence required for regulatory approval of orphan devices |
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09:30-10:00 |
Panel discussion |
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10:0--10:15 |
Coffee break |
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10:15-11:15 - BREAKOUT SESSIONS Moderated by: Alan Fraser and Eigil Samset (GE Healthcare) |
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Group 1: How to define unmet medical needs for devices |
Lead: Piotr Szymanski Rapporteur: Donal O’Conor |
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Group 2: Provisional/conditional approval vs full approval |
Lead: Robert Byrne Rapporteur: Archano Rao |
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Group 3: How to increase effectiveness of the EU regulatory medical device evaluation system – priorities for further reform |
Lead: Franz Weidinger |
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11:15 -11:30 |
Coffee break |
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|
11:30-11:40 |
Report from breakout session 1 – 10 mins |
Rapporteur: Donal O’Conor |
|
11:40-11:50 |
Report from breakout session 2 – 10 mins |
Rapporteur: Archana Rao |
|
11:50-12:00 |
Report from breakout session 3 – 10 mins |
Rapporteur: Patrick Myers |
|
12:00 -12:10 |
Wrap-up, conclusions, next steps for publication |
Chairpersons |
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END OF DAY 2 |
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12:15 |
Buffet lunch and departures |
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Biographies
- Prof. Thomas F. LÜSCHER, UK
- Prof. Stephan WINDECKER, Switzerland
- Prof. Piotr SZYMANSKI, Poland
- Prof. Eigil SAMSET, GE Healthcare
- Prof. Alan FRASER, UK
- Prof. Mitchell KRUCOFF, USA
- Prof. Giulio STEFANINI, Italy
- Dr. Alphons VINCENT, Medtronic
- Prof. Ralph Stephan VON BARDELEBEN, Germany
- Prof. Martine GILARD, France
- Ms. Inga DROSSART, Belgium
- Mr. John BRENNAN, Medtronic
- Mr. Andrea RAPPAGLIOSI, Edwards Lifesciences
- Prof. Ajay KIRTANE, USA
- Dr. Patrick MYERS, Switzerland
- Dr. Gearóid McGAURAN, Ireland
- Prof. Leila ABID, Tunisia
- Associate Professor. Lia CROTTI, Italy
- Mr. Mario GABRIELLI COSSELLU, Belgium
- Prof. Robert BYRNE, Ireland
- Dr. Radoslaw PARMA MD PhD, Poland
- Dr. Archana RAO, UK
- Dr. Jennifer FRANKE, Philips
- Dr. Jana KURUCOVA, Edwards Lifesciences
- Mr. Paul PISCOI, Belgium
- Dr. Andrew FARB, FDA
- Dr. Bram ZUCKERMAN, FDA
- Dr. Changfu WU, FDA
- Prof. Franz WEIDINGER , Austria
- Dr. Donal B O’CONNOR, Ireland
Our mission: To reduce the burden of cardiovascular disease.