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: Antónia Mészáros
09:00
OPENING
ENG
Organizers’ Welcome
Speaker
Attila Juhász
Professional Leader, SAASCO
Speaker
András F. Tóth
Head of the QTICS Medical Division
09:10
OPENING
ENG
Opening Speech
Speaker
Prof. dr. Levente Kovács
Rector, Obuda University
09:20
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
09:45
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
Coffee Break
ENG
10:30
PANEL DISCUSSION
ENG
The state and outlook of the European medical technology industry 🇬🇧 (🎧 🇭🇺)
Moderator
Miroslav Palat
President, CzechMed
Participant
Jesús Rueda Rodríguez
Director General Strategies, Special Projects and International Affairs, MedTech Europe
Participant
Dr. Christina Ziegenberg
Head of Regulatory Affairs, BVMed
Participant
Hans Hofstraat
Director of Business Development Life Sciences, Utrecht Science Park
Participant
Marco Wendel
Member of the Executive Board, Medical Valley EMN e.V.
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?
Moderator: Anni Koubek, CEO, QMD Services
11:15
PANEL DISCUSSION
ENG
MDR - IVDR transition experiences of Notified Bodies🇬🇧 (🎧 🇭🇺)
Moderator
Anni Koubek
CEO, QMD Services
Participant
Ana Pribakovic Borstnik
Deputy Director of Management Systems Assessment, SIQ Ljubljana
Participant
Curtis Riley
Head of Notified Body, Intertek Medical Notified Body AB
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
Participant
Katarzyna Wesołowska
CEO, MDR Regulator
Participant
Francisco Rodriguez
PhD Medtech Manager| Lead Auditor, Asphalion
14:00
PRESENTATION
ENG
I3HIES – An International Health Innovation Ecosystem to address MDR challenges 🇬🇧 (🎧 🇭🇺)
Speaker
Dr. Zsolt Pásztor
CEO, PREMET Ltd.
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
Project Lead for Regulatory Affairs, Software & AI at Metecon
14:45
Coffee Break
ENG
15:00
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.
15:00
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.
15:20
Presentation
ENG
Quantitative Medical Imaging: The Future of Diagnostics🇬🇧 (🎧 🇭🇺)
Speaker
Krisztián Szigeti PhD
Founder, Kinepict Health Ltd.
15:35
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)
15:50
PANEL DISCUSSION
ENG
The practical applications of AI🇬🇧 (🎧 🇭🇺)
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
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
