Congress Program

 Monday, 2 July

07:30-17:00

Registration 

08:00-08:50

One On One Meetings with Congress Speakers

08:50-09:00

Welcome and Opening of the Congress

09:00-10:30

Session 1

 09:00-09:40

Start Up Nation, the Medical Device Industry and Regulatory Environment in Israel
Eng. Adi Ickowicz, Founder and CEO, MedicSense (Israel and USA)

09:40-10:20

The Impact and Consequences of the New EU MDR / IVDR Regulations on the EU MedTech Ecosystem
Mr. Beatus Hofrichter, Founder & CEO - ConCeplus (Switzerland)

 10:20-10:30
 Discussion

10:30-11:00

Networking, Coffee Break and visit the Exhibition

 11:00-12:30

Session 2

11:00-11:40 

Optimizing Generation of Clinical Evidence for Medical Devices
Eng. Jón Ingi Bergsteinsson – Co Founder of SMART-TRIAL (Denmark)

11:40-12:20 

Achieving Clinical Development Success Through a CRO
Ms. Nancy Boodhun
Clinical and Consulting Specialist, NAMSA (UK)

12:20-12:30

Discussion

12:30-13:30

Lunch Break and visit the Exhibition

 13:30-14:00

Can Medical Devices Learn from Pharma: Shared Challenges, Similar Opportunities!
Mr. David Scanlon
Senior Director of Regulatory Strategy, ARISGLOBAL (UK)

14:00-15:30

Session 3

14:00-14:40

The Regulatory Process for Medical Devices in China
Dr. Chao Xu, Co-founder, J MedTec  (China)

14:40-15:20

The Medical Device Regulatory Environment in the Eurasian Economic Union
Mr. Maxim Bagreev,
CEO, Cratia (Ukraine)

 15:20-15:30
Discussion

15:30-16:00

Networking, Coffee Break and visit the Exhibition 

16:00-17:00

Session 4

16:00-16:50 

The role of the European Authorized Representative in the New MDR/IVDR Era
Eng. Ton Pennings
Director, CEpartner4U (the Netherlands)

 16:50-17:00
Discussion

17:00-18:00

One On One Meetings with Congress Speakers

Tuesday, 3 July

07:30-16:30

Registration

08:00-09:00

One On One Meetings with Congress Speakers

09:00-10:30

Session 5

 09:00-09:40

The New European Regulation (MDR) from a Notified Body Perspective
Eng. Vanessa Biavati, Ente Certificazione Macchine - ECM (Italy)

09:40-10:20

Medical Devices Cybersecurity and Data Transfer Management, What we Need to Know
Ms. Dina Sifri, CEO & Founder, Med-Dev Design (Israel)

 10:20-10:30
Discussion

10:30-11:00

Networking, Coffee Break and visit the Exhibition 

11:00-12:30

Session 6

 11:00-11:40

Medical Devices and Regulatory Affairs in Turkey
Eng. Basak Baranoğlu DemirciFounder, AdviQual (Turkey)

 11:40-12:20

Human Factors and Design for Usability of Medical Devices
Eng. Rebecca Margolies Moses
Director, Core Human Factors (USA)

 12:20-12:30
Discussion

12:30-13:30

Lunch Break and visit the Exhibition

13:30-15:00

Session 7

 13:30-14:10

Health Economics: Getting Ready for Health Technology Assessment
Dr. Adi Nir
PhD.MSc (Israel)

 14:10-14:50

Post Market Surveillance:  from Reducing Risks to Value Creation
Mr. Alexander Steffen
Director Human Factors, Bayoonet AG (Germany)

 14:50-15:00

 Discussion

15:00-15:30

Networking, Coffee Break and visit the Exhibition 

15:30-16:30

Session 8

 15:30-16:20

The Golden Triangle in the Medical Device Industry
Intellectual Property, Regulatory Affairs and Reimbursement
Mr. Erez Adiv, Founder & CEO, MedicSense (Israel)

 16:20-16:30
Discussion

 16:30

Congress Closing remarks