Congress Agenda

Monday, 16 October 2017


 07:00 Registration 
 08:00
Chairman’s Introduction

Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK

 08:15
Setting the Scene: The Political and Technological Framework during the Lifetime of the New Regulatory System  
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK
                     
 08:45
Overview and Implementation of the New Regulatory System     
Amanda Maxwell, Medtech Regulatory Affairs Editor, Clinica, Informa Healthcare, UK

 09:30

Major Regulatory Compliance Challenges
Dario Pirovano, Senior Regulatory Adviser, MedTech Europe

 10:15 Coffee Break and visit the Exhibition
 10:45
Challenges for National Competent Authorities
Graeme Tunbridge, Group Manager - Devices Regulatory Affairs, Medicines & Healthcare Products Regulatory Agency (MHRA), UK

 11:30
New Legal Challenges to the Medical Device Industry
Hanneke Later-Nijland, Axon Lawyers, The Netherlands

 12:15  
Scope, Borderlines and Classification
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK

12:45 Lunch Break and visit the Exhibition
13:45
General Safety and Performance Requirements
 
Roger Gray, Member of the Board, EAAR; Vice President, Quality and Regulatory, Donawa Lifescience Consulting, Italy

14:30  
Clinical Evaluation
Sarah Sorrel, Member of the Board, EAAR; President,  Medpass International, France

15:15 Coffee Break and visit the Exhibition
15:45
Quality Systems
Maurizio Suppo, Member of the Board, EAAR; Principal Consultant, Qarad, Belgium

16:30
Conformity Assessment & Notified Bodies
Hans-Heiner Junker,
Senior International Affairs Manager, TÜV SÜD Product Service, Germany
         
17:15 End of Day One

Tuesday, 17 October 2017

08:00 Registration 
08:45
Post-Market Surveillance  
Ludger Möller, Vice-Chairman, EAAR; President, Medical Device Safety Service GMbH, Germany

09:30
Post-Market Clinical Follow Up
Sarah Sorrel, Member of the Board, EAAR; President,  Medpass International, France

10:15 Coffee Break and visit the Exhibition
10:45
Traceability (Eudamed, UDI) 
Ronald Boumans, Member of the Board, EAAR; Senior Global Regulatory Consultant, Emergo, The Netherlands

11:30
Vigilance
Ludger Möller, Vice-Chairman, EAAR; President, Medical Device Safety Service GMbH, Germany

12:15
Lunch Break and visit the Exhibition
 13:15  Compliance Requirements for Authorized Representatives  
Sandra Ferretti, Member  of the Board, EAAR; Chief Compliance Officer, Obelis s.a., Belgium
14:00
Special IVD Issues
Maurizio Suppo, Member of the Board, EAAR; Principal Consultant, Qarad, Belgium

14:45
Coffee Break, visit the Exhibition
15:15  
Software 
Robert GinsbergMember of the Board, EAAR; Chairman of the Board, QAdvis, Sweden

16:00
Conflicts Between Economic Operators  
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK
                                             
16:45
Round Table: Will the New Regulatory System Work
All Speakers

 
17:30  End of Congress