Congress Agenda

Monday, 7 November



 07:00
Registration
 


 08:00 - 08:15                     

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

 08:15 – 09:45

Future of Europe

-  Overview of the New Regulatory System
-  Political and Technological Challenges
                       

Amanda MaxwellMedtech Regulatory Affairs Editor, Clinica, Informa Healthcare, UK
Mika ReinikainenChairman EAAR; Managing Director, Abnovo Ltd, UK

 
09:45 – 10:30

Challenges for National Competent Authorities   

Adrian Bartlett, EU Policy Manager, Medical Devices, Medicines and Healthcare Products Regulatory Agency (MHRA), UK   
 

10:30 – 11:00
 
Coffee Break


11:00 – 11:45 

New Legal Challenges to the Medical Device Industry

Erik Vollebregt, Partner, Axon Lawyers, Netherlands


11:45 – 12:30

General Safety and Performance Requirements 

Oliver Bisazza, Director Regulatory Policy EMEA, Medtronic, Belgium

 12:30 – 13:30 

Lunch Break

 
13:30 – 14:15

Clinical Evaluation
Sarah SorrelMember of the Board, EAAR; President,  Medpass International, France

 
14:15 – 15:00

Post-Market Clinical Follow Up                                                         
Sarah SorrelMember of the Board, EAAR; President,  Medpass International, France

 
15:00 – 15:30
 
Coffee Break  

 
15:30 – 16:15
 
Quality Systems                                                           
Maurizio Suppo, Member of Board, EAAR; Principal Consultant, Qarad, Belgium


16:15 – 17:00
     
Conformity Assessment & Notified Bodies           
Bassil Akra, Director – Global Clinical Centre of Excellence (cCE), TÜV SÜD PRODUCT SERVICE, Germany

Tuesday, 8 November

08:00                              
Registration
 


08:45 – 09:30

Worst Case Scenario: Potential Pitfalls of the New System
Sandra Ferretti Member  of the Board, EAAR; Chief Compliance Officer, Obelis s.a., Belgium    


09:30 – 10:15

Post-market Surveillance
Ludger Möller,
 Vice-Chairman, EAAR; President, Medical Device Safety Service GMbH, Germany

10:15 – 10:45

 Coffee Break

 
10:45 – 11:30            
  
Traceability (Eudamed, UDI)
Ronald Boumans, Member of the Board, EAAR; Senior Global Regulatory Consultant, Emergo, Netherlands  
  

11:30 – 12:30

Roundtable:  Is it Possible to Achieve Compliance in Time?   
All speakers



12:30 – 13:30
 
Lunch Break

 
13:30– 14:15

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

 
14:15 – 15:00

Scope, borderlines and classification
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK 

 
15:00 – 15:30
 
Coffee Break  


15:30 – 16:15

Special IVD issues
Maurizio Suppo,
 Member of Board, EAAR; Principal Consultant, Qarad, Belgium

 
16:15 – 17:00

Software

Robert Ginsberg,
 Member of the Board, EAAR; Chairman of the Board, QAdvis, Sweden


17:00 – 17:45
Economic Operators                                     
Mika ReinikainenChairman EAAR; Managing Director, Abnovo Ltd, UK