Preliminary programme
Please note that this programme is subject to change.
Venue of the Meeting
MTA Hungarian Academy of Sciences
Budapest, Széchenyi István tér 9, 1051
Venue of the Welcome Event
Budapest, Olof Palme prom. 5., 1146
Venue of the Gala Dinner
Budapest, Olof Palme prom. 5., 1146
26 NOVEMBER (TUESDAY) – CAMD CEG
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09:30 – 17:00 |
EU CEG meeting for the executive group |
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19:00 - 21:00 |
Welcome drink (Venue: Városliget Café) |
27 NOVEMBER (WEDNESDAY)
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08:00 - 09:00 |
Registration |
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09:00 - 10:00 |
Session 1: welcome and introduction Chair: Norbert Kovács Opening – Dr. Pálffyné Poór Rita 5’ Adoption of the agenda – Norbert Kovács 5’ Review of the previous CAMD meeting - Katrien Martens/Alexandre Jauniaux presentation 10’ History of the hungarian medical devices industry – Norbert Kovács 20’ Introduction of the Hungarian Department of Medical Devices 10’ Discussion 10’ |
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10:00– 10:15 |
Coffee Break |
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10:15 -11:40 |
Session 2: Update CAMD and commission Chair: Nicola Hickie CAMD Executive Group – Thierry Sirdey 20’ Update of CAMD/CEG ToR and RoP – Caroline Chiumia/Wolfgang Lauer 25’ Update of the EU commission – Flora Giorgio 20’ Update of JAMS 2.0 – Caroline Chiumia 20’ |
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11:40-12:40 |
Lunch Break |
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12:40-14:40 |
Session 3: update on the application of the regulations Chair: Wolfgang Lauer Developement since July workshop and next steps – Nicola Hickie 20’ Update on targeted evaluation – Flora Giorgio 20’ Discussion on next step 20’ Implementation on Art. 10a Q&A and manufacturer information form) – Thierry Sirdey / Orla Daly 20’ CAMD Discussion 20’ |
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14:40-14:55 |
Coffee Break |
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14:55 -16:30 |
Session 4: clinical session Chair: Ferenc Bodnár Hungarian IVDR and MDR research: datas and experiences – Ferenc Bodnár 20’ ISO 14155:2020-07 Human clinical investigation using medical devices. Good Clinical Practice (Challenges in implementing clinical investigation) – Éva Reif 20’ Innovative Methods for Designing Medical Device Clinical Investigations (Challenges in implementing clinical investigation) – Dr. Péter Hársfalvi 20’ CORE – MD and coordinated assessment procedure IE –Donal O’Connor 15’ Discussion 15’ |
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19:00- 21:00 |
Social event and gala dinner (Venue: Városliget Café) |
28 NOVEMBER (THURSDAY)
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09:00 - 10:10 |
Session 5: main topic related to the regulation MDR/IVDR development – future tendencies Chair: Katrien Martens/Alexandre Jauniaux Overview, opinions of the future of MDR/IVDR regulations by DA - Rainer Edelhäuser 20’ Oveview of JAT related to NB designation (- Expectations on the reassessment of NBs) – Mairead Flinucane 15’ Harmonization of AI Act with MDR/IVDR – Nada Alkhayat 20’ Discussion 15’ |
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10:10– 10:20 |
Coffee Break |
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10:20 -11:20 |
Session 6: medical devices in healthcare Chair: Mariana Madureira/Judite Neves Medical device hospital follow up in Hungary - Christine Horváth-Hankó 20’ Periodic review of medical devices – Norbert Kovács 20’ CMD: supervision, registration, accountability – Dalma Szombathy 20’ |
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11:20– 11:30 |
Coffee Break |
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11:30-12:30 |
Session 7: meeting closure Chair: Norbert Kovács Lifetime achievement awards Conclusions and Follow up 10’ Next Presidency of the Council Polish CA – Aleksandra Rodatus 10’ |
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13:00- |
Lunch and farewell |
Accommodation
The members of the delegations are responsible for their own reservation arrangements and covering the cost of their hotel rooms. Any additional expenses (beverages, minibar, parking, meals, laundry services, etc.) must be covered by the delegates themselves.
Our hotel recommendations:
Upper category
Middle category
Adina Apartment Hotel Budapest
Budget category