Congress Program

Monday, 15 May


 07:30  Registration 
 08:20  Welcome and Opening of the Congress
 08:30  Session I
 
08:30-09:10
Regulatory Strategy – Key Success Factor for an Effective Product Development and Commercialization 
Stephan Buttron
, Principal Medical Research Manager Regulatory Affairs, NAMSA, Germany

09:10-09:50
The New EU MDR: Background on Creation and Main New Topics
Robert van Boxtel
, Principle Consultant Medical Device Project B.V., The Netherlands

09:50-10:00
Discussion

 10:00 Networking Break and visit the Exhibition
One-on-One Meetings

 10:30  Session II
 
10:30-11:10
The FDA Expedited Access Pathway (EAP) for Unmet Medical Need, Life Threatening or Irreversibly Debilitating Diseases or Conditions
Susan Alpert,
Former Senior VP Chief Regulatory Officer of Medtronic, VP Regulatory Sciences for C.R. Bard, Inc. and FDA Director of the ODE, USA

11:10-11:50
e-Labeling and Medical Devices
Maurizio Suppo
, Principal Consultant, QARAD, Belgium

11:50-12:00
Discussion

 12:00 Lunch Break, Networking and visit the Exhibition

 13:00  Session III
 
13:00-13:40
Cyber and Information Security Management Systems (ISMS) - The Next Big Thing!!
Philippe Cohen, CEO, Shefing, Israel
            
13:40-14:20
The Medical Device Law in Israel and the IRH role
Adi Ickowicz, CEO, MedicSense Ltd, USA/Israel/Belgium

14:20-14:30
Discussion

 14:30 Networking Break and visit the Exhibition
One-on-One Meetings
 15:00  Session IV
 
15:00-15:40
Plan for the Medical Device Single Audit Program (MDSAP)
Louis-Paul Marin, President - LOK North America (Canada)

15:40-16:20
Internet of Things (IoT) in Medical Devices, Everybody Talks with Everyone….
Philippe Cohen, CEO, Shefing, Israel

16:20-16:30
Discussion

 16:30  End of Day One

 
Tuesday, 16 May

 07:30 Registration 
 08:30  Session V
 
08:30-09:10
Expected Regulatory Changes in South America
Andrea Martinez-Saud, Country Manager, Atlantis Clinical LLC, USA 

09:10-09:50
Interaction between the New EU Regulation and Reimbursement  
Dr. Lea Koelemeijer, Crefact consultants
The Netherlands

09:50-10:00
Discussion

 10:00 Networking Break and visit the Exhibition

 10:30  Session VI
 
10:30-11:10
Biological Safety, Current Requirements and Approach 
Sylvie Framery
, Senior Principal Medical Research Scientist , NAMSA

11:10-11:50
Medical Software/Apps – A regulatory introduction on MDD and MDR 
Ittipan Kanluan, CE Plus, Germany

11:50-12:00
Discussion
 12:00
Lunch Break, Networking and visit the Exhibition

 13:00 Session VII
 
13:00-13:40
Prepare Yourself for an FDA Audit 
Susan Alpert
, Former Senior VP Chief Regulatory Officer of Medtronic,VP Regulatory Sciences for C.R. Bard, Inc. and FDA Director of the ODE, USA

13:40-14:20
Clinical Evaluation, the Role of the EU NB
Harry van Vugt
Project Manager Medical Devices and Certification Manager, DEKRA, Germany/The Netherlands

14:20-14:30
Discussion

 14:30
Networking Break and visit the Exhibition
 15:00  Session VIII
 
15:00-15:40
Cleaning, Disinfection and Sterilization – What is in between
Nicola Revellin,
NAMSA

15:40-16:20
The Power of Backward and Forward Traceability
Wolfgang Huber, CEO, Matrix Requirements, Germany

16:20-16:30
Discussion

 16:30   Closing Remarks