LSA 2021: Review
The Lübeck Summer Academy occured on 16th June 2021, 9 am to 4 pm, online.
Regulatory affairs for medical devices
The Medical Device Regulation (MDR) transition period ended in May 2021. In our session on Regulatory Affairs we discussed the topic from various perspectives, including industry and notified bodies. The session was organised by Life Science Nord’s Working Group on Regulatory Affairs.
Artificial Intelligence and Deep Learning
Ethical implications of AI and Deep Learning solutions are often discussed, including in medicine. Results of these discussions now gradually flow into European and national regulations, technical standards, and norms. A risk-based approach, familiar from other European regulations, such as the Medical Device and the IVD regulations, is being developed. We provided an overview on state of play and presented exiting examples of recent AI / DL-based solutions in medicine.
LSA2021 was organised as an online conference.
Programme, recordings and presentations
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08.50
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Attendees‘ login
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09.00
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Welcome
Folker Spitzenberger, Conference committee, Centre for Regulatory Affairs in Biomedical Sciences (CRABS), Technische Hochschule Lübeck / Lübeck University of Applied Sciences
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Session I: Regulatory Affairs
Session chair: Folker Spitzenberger |
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09.10
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Keynote 1: The European AI Regulation
Salvatore Scalzo, Policy and Legal Officer, AI Policy Development and Coordination Unit, EU Commission, Brussels
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1971 KB).
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09.50
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Aspects of the European and German Regulatory Framework for Medical Devices -
A Notified Bodies' Perspective Julia Hoyer, TÜV SÜD Product Service GmbH, Medical Health Services, Munich
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1653 KB).
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10.20
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The New Regulatory Framework for Medical Devices – An Industry Perspective
Christina Ziegenberg, BVMed – The German Medical Technology Association, Berlin
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1138 KB).
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10.50
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The New Regulatory Framework for Medical Devices – The Dräger Roadmap
Volker Ständer, Drägerwerk AG & Co. KGaA, Lübeck
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1878 KB).
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11.20
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Five-minute break |
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11.25
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Panel discussion (I)
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12.00
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Bring your own lunch
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Session II: AI & Deep Learning
Session chairs: Johannes Lotz, Dirk Hermsmeyer |
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12.45
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Keynote 2: German Standardization Roadmap AI
Wolfgang Wahlster, German Research Centre for Artificial Intelligence, DFKI
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 3965 KB).
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13.25
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Overcoming Data Silos: The AI Collaboration Toolkit for Health Data
Hans Meine, Fraunhofer MEVIS, Bremen
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1610 KB).
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13.55
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Practical Aspects of AI in Medical Devices
Arpad Bischof, IMAGE Information Systems, Rostock
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1490 KB).
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14.25
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Reimagining Medicine: Prescription Digital Therapeutics Powered by Personalized Nutrition
Dominik Burziwoda, Perfood GmbH, Lübeck
Here you can download the presentation (nicht barrierefrei, PDF-Datei · 1409 KB).
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14.55
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Five-minute break
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15.00
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Panel discussion (II)
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15.35
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Social gathering (online)
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