Symposium Agenda

Monday, 22 October 2018

 

 07:00-08:00

Registration 

 08:00-08:15

Chairman’s Introduction
Mika Reinikainen, 
Chairman EAAR; Managing Director, Abnovo, UK

 08:15-09:00

Implementation of the New Regulations  
TBC, Commission of the European Union

 09:00-09:45
 
The Road to 2020: Overview of Regulatory Developments
Amanda Maxwell, Medtech Regulatory Affairs Editor, Medtech Insight, Informa Healthcare, UK

09:45-10:30

Major Regulatory Compliance Challenges for the Industry
Dario Pirovano, Senior Regulatory Adviser, MedTech Europe

10:30-11:00

Coffee Break and visit the Exhibition

11:00-11:45

Challenges for National Competent Authorities
TBC, Competent Authority Speaker, Belgium

11:45-12:30

New Legal Challenges to the Medical Device Industry
Erik Vollebregt, Partner, Axon Lawyers, The Netherlands

12:30-13:00

Scope, Borderlines and Classification
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo, UK

13:00-14:00

Lunch Break and visit the Exhibition

 

14:00-14:40

General Safety and Performance Requirements 
TBC

14:40-15:20

Practical Aspects of Clinical Evaluation: What Needs to be Updated Now and How to Plan for Future Compliance Under the MDR
Sarah Sorrel, Member of the Board, EAAR | President, Medpass International, France

15:20-15:30

Spotlight Presentation
Sponsored by 
Evidence Partners

15:30-16:00

Coffee Break and visit the Exhibition

16:00-16:45

Impact of the MD/IVD-Regulations on Quality Management Systems
Maurizio Suppo, 
Member of the Board, EAAR; Principal Consultant, Qarad, Belgium

16:45-17:30

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

17:30

End of Day One

 

Tuesday, 23 October 2018

 

08:00-08:45

Registration 

08:45-09:30

Post-Market Surveillance  
Ludger Möller, 
Vice-Chairman, EAAR | President, Medical Device Safety Service, Germany

09:30-10:15

Do you Need to Plan for PMCF and What are the Possibilities for Gathering PMCF Data?
Sarah Sorrel, Member of the Board, EAAR | President, Medpass International, France

10:15-10:45

Coffee Break and visit the Exhibition

10:45-11:30

The Impact of Increased Transparency and Traceability Resulting from Eudamed and the Introduction of UDI
Ronald Boumans, 
Member of the Board, EAAR | Senior Global Regulatory Consultant, Emergo, The Netherlands

11:30-12:15

Vigilance
Ludger Möller, Vice-Chairman, EAAR | President, Medical Device Safety Service, Germany

12:15-13:15

Lunch Break and visit the Exhibition

13:15-14:00

What can we Expect from the MDR Autorised Representative?
Sandra Ferretti, Member of the Board, EAAR | Chief Compliance Officer, Obelis, Belgium

14:00-14:45

Special IVD Issues
Maurizio Suppo, Member of the Board, EAAR | Principal Consultant, Qarad, Belgium

14:45-15:15

Coffee Break and visit the Exhibition

15:15-16:00

Software
Robert Ginsberg
Member of the Board, EAAR | Chairman of the Board, QAdvis, Sweden

16:00-16:45

Conflicts Between Economic Operators   
Mika Reinikainen, Chairman EAAR | Managing Director, Abnovo, UK                                            

16:45-17:30

Round Table: Will the New Regulatory System Work
All Speakers 

17:30 

End of Congress