08:15-09:00
|
Registration
|
09:00-09:45
|
Challenges Arising from the New Concepts in the Regulations Relating to Scope, Classification and General Safety and Performance Requirements
Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
|
09:45-10:30
|
Practical Aspects of Clinical Evaluation: Before and After CE Marking under the MDR
Sarah Sorrel, EAAR Member of the Board, President, Medpass International, France
|
10:30-11:00
|
Coffee Break, Networking and Visit the Exhibition
|
11:00-11:45
|
Eudamed and UDI, a Curse in Disguise
Ronald Boumans, EAAR Member of the Board, Senior Global Regulatory Consultant, Emergo, The Netherlands
|
11:45-12:30
|
Major Regulatory Compliance Challenges for the Industry
Dario Pirovano, Senior Regulatory Adviser, MedTech Europe, Belgium
|
12:30-13:30
13:00-13:30
|
Lunch Break, Networking and Visit the Exhibition
One-To-One Meeting with Speakers
|
13:30-14:15
|
What can we Expect from the MDR Autorised Representative?
Sandra Ferretti, EAAR Member of the Board, Chief Compliance Officer, Obelis, Belgium
|
14:15-15:00
|
Special IVD Issues
Kirsten Van Garsse, Regulatory Affairs Manager, Qarad, Belgium
|
15:00-15:45
|
Medical Device Software in the European Union
Robert Ginsberg, EAAR Member of the Board, Chairman of the Board, QAdvis, Sweden
|
15:45-16:15
|
Coffee Break, Networking and Visit the Exhibition
|
16:15-17:00
|
Conflict Between Economic Operators
Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
|
17:00-17:30
|
Panel Discussion: Will it be a Hard of Soft Landing? For the Many of the Few?
All Speakers
|
17:30
|
Conference Closing
Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
|