Conference Agenda


Monday, 28 October 2019

        08:00-08:45

Registration

08:45-09:00

Welcome and Opening of the Conference
Conference Chair: Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK

09:00-09:45 

Implementation of the New Regulations: State of the Play
Erik Hansson, Deputy Head of Unit, Health Technology and Cosmetics, DG GROW, European Commission, Belgium

 09:45-10:30

View of a Notified Body on the MDR Implementation Steps
Bassil Akra, Vice-President, TÜV SÜD Product Service, Germany

10:30-11:00

Coffee Break, Networking and Visit the Exhibition

 11:00-11:45

Designation of Notified Bodies: State of Play
Françoise Schlemmer, 
Director, Team-NB, Belgium

11:45-12:30 

Seven Months to Go: Are Recent and Ongoing Developments Enough?
Amanda Maxwell
Medtech Regulatory Affairs Editor, Medtech Insight, Informa Healthcare, UK

12:30-13:30 
13:30-14:00
 
Lunch Break, Networking and Visit the Exhibition 
One-To-One Meeting with Speakers

 14:00-14:45

The Knowns and the Unknowns until May 2020 - What to Expect and What not to Expect, and How to Plan for it from a Legal Perspective
Erik Vollebregt, Partner, Axon Lawyers, The Netherlands

 14:45-15:30

Post-Market Surveillance - A New Concept OR a Great Misunderstanding / The Importance of Post Market Surveillance
Ludger Möller, 
EAAR Vice-Chairman, President, Medical Device Safety Service, Germany

15:30-16:00

Coffee Break, Networking and Visit the Exhibition

16:00-16:45 

Vigilance - Are There New Reporting Requirements? How is the New Market Surveillance Being Applied?
Ludger Möller, EAAR Vice-Chairman, President, Medical Device Safety Service, Germany

 16:45-17:30

The Role of GS1 as UDI Issuing Agency
Geraldine Lissalde-Bonnet
, Director, Public Policy-Healthcare, GS1, Belgium

 17:30-18:15

Impact of the MD/IVD-Regulations on Quality Management Systems 
Kirsten Van Garsse, Regulatory Affairs Manager, Qarad, Belgium 

      18:15

End of Day One


Tuesday, 29 October 2019

        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