Symposium Agenda


Monday, 22 October 2018

 

 08:00-09:00

Registration 

 09:00-09:15

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

 09:15-10:00

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

 10:00-10:45
 
The Road to 2020: Overview of Regulatory Developments
Amanda Maxwell, Medtech Regulatory Affairs Editor, Medtech Insight, Informa Healthcare, UK

10:45-11:15

Coffee Break and visit the Exhibition

 11:15-12:00
 
Major Regulatory Compliance Challenges for the Industry
Dario Pirovano, Senior Regulatory Adviser, MedTech Europe, Belgium

12:00-12:45

Challenges for National Competent Authorities
Valerie Nys, Federal Agency for Medicines and Health Products (FAMHP), Belgium

 12:45-13:45  
Lunch Break and visit the Exhibition

13:45-14:30

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

14:30-15:15

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

15:15-15:25

Spotlight Presentation
The Role of Automation in Maintaining Regulatory Compliant CER Literature Reviews
Peter O'Blenis, President, Evidence Partners
Sponsored by 
Evidence Partners

15:25-16:00

Coffee Break and visit the Exhibition

 16:00-16:30  
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

 16:30-17:00  
General Safety and Performance Requirements 
Mika Reinikainen, Chairman EAAR, Managing Director, Abnovo, UK

17:00-17:45

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

17:45

End of Day One

 

Tuesday, 23 October 2018

 

08:30-09:00

Registration 

 09:00-09:30  
Impact of the MD/IVD-Regulations on Quality Management Systems
Dirk Stynen,
Member of the Board, EAAR; President, Qarad, Belgium


09:30-10:00

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

10:00-10:30

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

 10:30-11:00
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

11:00-11:30

Coffee Break and visit the Exhibition

11:30-12:00

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

 12:00-12:30  
What can we Expect from the MDR Autorised Representative?
Sandra Ferretti, Member of the Board, EAAR | Chief Compliance Officer, Obelis, Belgium

12:30-13:30

Lunch Break and visit the Exhibition

13:30-14:15

Special IVD Issues
Dirk Stynen, Member of the Board, EAAR | President, Qarad, Belgium

 14:15-15:00
Software
Robert Ginsberg,
Member of the Board, EAAR | Chairman of the Board, QAdvis, Sweden


15:00-15:30

Coffee Break and visit the Exhibition

15:30-16:00

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

16:00-17:00

Round Table: Will the New Regulatory System Work
All Speakers 

17:00 

End of Congress