09:00
Plenary session 1
ENG
MDR/IVDR transition and innovation
The MDR/IVDR requires the full recertification of all medical
devices according to the new requirements. This transition
involves enormous costs, leading companies to withdraw a
significant portion of their devices from the market, or
smaller manufacturers to simply cease production.
Additionally,
during the transition period, no significant modifications to
the devices are possible. According to manufacturers, the
current European regulations stifle innovation. The first
regulatory approvals for innovative medical devices have
shifted from Europe to the United States. How, then, can
European medical innovation be sustained within the current
regulatory framework, or how should the regulations be changed
to reinvigorate innovation?
Moderator on request.
09:00
GREETING
ENG
Greeting
Speaker
Prof. dr. Levente Kovács
Rector, Obuda University
09:10
Presentation
ENG
What lies ahead for the European medical technology industry?
Speaker
Jesús Rueda Rodríguez
Director General Strategies, Special Projects and International Affairs, MedTech Europe
09:30
Presentation
ENG
Title to be confirmed
Speaker
Speaker to be confirmed
09:45
Presentation
ENG
BVMed's MDR/IVDR development proposals (and their current status)
Speaker
Dr. Christina Ziegenberg
Head of Regulatory Affairs, BVMed
10:00
Presentation
ENG
Digitalization as the key to future development of MDR and IVDR
Speaker
Michael M. Kania
CEO, meddevo dytab GmbH
10:15
Q&A
ENG
10:30
Coffee Break
ENG
10:45
PANEL DISCUSSION
ENG
The state and outlook of the European medical technology industry
Moderator
Moderator
to be confirmed
Participant
Jesús Rueda Rodríguez
Director General Strategies, Special Projects and International Affairs, MedTech Europe
Participant
Dr. Christina Ziegenberg
Head of Regulatory Affairs, BVMed
11:15
Plenary session 2
HUN
MDR/IVDR transition experiences
In the past period, especially after the MDR's mandatory application deadline of 05/26/2024, more and more CE certificates have been issued, so all involved actors have more and more experience. How do notified organizations see the submitted technical documentation? What kind of experiences can the consultants pass on?
11:15
PANEL DISCUSSION
ENG
MDR - IVDR transition experiences of Notified Bodies
Moderator
Anni Koubek
CEO, QMD Services
Participant
Ana Pribakovic Borstnik
Medical department director, SIQ, Slovenia
Participant
Martin Tettke
Head of CB / NB, Berlincert, Germany
Participant
Tomasz Koeber
Head of Medical Devices Certification Department, PCBC Poland
11:45
Q&A
ENG
12:00
Lunch Break
ENG
13:30
PANEL DISCUSSION
ENG
MDR - IVDR transition consultant experiences
Moderator
Csaba Sántics
Consultant, SAASCO Ltd.
Participant
Árpád Zsolt Bús
Division leader, SAASCO Ltd.
Participant
Tabatha Bourgois
Business Development Director - Regulatory Affairs, Alira Health
14:15
Plenary session 3
HUN
New horizontal requirements
The medical technology industry's burdens related to the MDR/IVDR transition will be further increased by the EU's new horizontal legislation to be introduced in the near future. What new horizontal requirements appear? How can these requirements be met?
14:15
PRESENTATION
ENG
The medical device industry is in the crosshairs of the new horizontal requirements
Speaker
Attila Juhász
Professional Leader, SAASCO Kft.
14:30
PRESENTATION
ENG
AI Meets Medtech
Speaker
Thorsten Stumpf
Metecon
15:15
Plenary session 4
HUN
The practical applications of AI
So far, we have only talked about the huge potential of
Artificial Intelligence (AI), but free generative AI
applications have democratized the technology, making it
accessible to anyone. It has become clear that anyone who does
not use AI, including even to make their daily work more
efficient, will be at a competitive disadvantage in the
market. But what, how can you use AI? What results can we
expect from the application of AI?
Moderator: Nóra SZALÓCZY, healthcare ML Consultant, Neuron
Solutions Ltd.
15:15
Presentation
ENG
The AI Ecosystem in Pharma and Healthcare: Integrating Traditional and Generative AI Approaches
Speaker
Gyula Kovács
Co-founder and managing director, Neuron Solutions Ltd.
15:30
Presentation
ENG
Quantitative Medical Imaging: The Future of Diagnostics
Speaker
Krisztián Szigeti PhD
Founder, Kinepict Health Ltd.
15:45
Presentation
ENG
Application of AI in new drug discovery at Gedeon Richter
Speaker
Kristóf Kelemen
Biostatistician, Richter Gedeon Plc.
16:00
Presentation
ENG
AI-Driven Integration of Pharmacovigilance into the Drug Discovery Pipeline
Speaker
Dr. Péter Antal
Associate professor, Department of Artificial Intelligence and Systems Engineering Budapest University of Technology and Economics (BME), Faculty of Electrical Engineering and Informatics (VIK)
16:15
PANEL DISCUSSION
ENG
Title to be confirmed
Moderator
Nóra Szalóczy
Healthcare ML Consultant, Neuron Solutions Ltd.
Participant
Gyula Kovács
Co-founder and managing director, Neuron Solutions Ltd.
Participant
Krisztián Szigeti PhD
Founder, Kinepict Health Ltd.
Participant
Kristóf Kelemen
Biostatistician, Richter Gedeon Plc.
Participant
Dr. Péter Antal
Department of Artificial Intelligence and Systems Engineering Budapest University of Technology and Economics (BME), Faculty of Electrical Engineering and Informatics (VIK)
19:00
Dinner
