Congress Program

Thursday, 7 September

07:30  Registration 
08:50
Congress Opening and 
Welcome Address

 09:00
Session I


  09:00-09:30
Deciding When to Perform a Clinical Trial with Medical Devices
Wiebe Postma
, Consultant, Qserve Group EU, The Netherlands

09:30-10:00
Safety Verification Prior to Safety Validation
Erez Adiv, co-CEO and Founder - MedicSense Ltd, USA/Israel/Belgium

10:00-10:30
Clinical Trials with Drug-Device Combinations
Yair Alegranti
, CEO, TRS Ltd, Israel

10:30
Coffee Break and visit the Exhibition
One-on-One Meetings with KOL

11:00
Session II


  11:00-11:30 
Optimizing Generation of Clinical Evidence for Medical Devices -The Pros and Cons of Trials in the 21st Century
Jón Ingi Bergsteinsson
Co-Founder and CTO of SMART-TRIAL, Denmark

11:30-12:00
Clinical Evaluation and the New EU MEDDEV 2.7.1/rev 4
Giovanni Di RienzoGlobal Director, Cardiovascular Focus Team - TÜV SÜD Product Service, UK

12:00-12:30
EU MDR and Clinical Evidence – What is in Between?
Giovanni Di Rienzo
Global Director, Cardiovascular Focus Team - TÜV SÜD Product Service, UK

12:30
Lunch Break and visit the Exhibition
One-on-One Meetings with KOL

13:30
Session III


  13:30-14:00
FDA Significant Risk (SR) and Nonsignificant Risk (NSR) Medical Device Studies
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

14:00-14:30
Current Regulations of Clinical Trials with Medical Devices in Brazil
Andrea Saud Martinez, Country Manager, Avanti Pesquisas Clinicas, Brazil

14:30  
Coffee Break and visit the Exhibition
One-on-One Meetings with KOL

15:00
Session IV


  15:00-15:30
The Role of Academia in Medical Device Validation and Translation
Les Kalman, Chair, Dental Outreach Community Service - Schulich School of Medicine & Dentistry, Western University, Canada

15:30-16:00
Successful Delivery of Early Phase, Proof of Concept, Late Phase Pivitol Trials
Divya Chadha Manek, NIHR Clinical Research Network, UK

16:00-16:30
Design a Clinical Program for Success
James Nolan, CEO, InClinica, USA

 16:30  End of Day One

Friday, 8 September


08:30  Registration 
09:30
Session V


  09:30-10:00
Sterilization Validation Consideration for Clinical Trials, Full Validation vs. Single Batch Release
Erez Adiv, co-CEO and Founder - MedicSense Ltd, USA/Israel/Belgium

10:00-10:30
How to do a Clinical Trial in China
Wei Zhang, Project Manager, Osmunda, Germany

10:30-11:00
FDA Expedited Access Pathway (EAP) for Unmet Medical Need for 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

11:00
Coffee Break and visit the Exhibition

11:30
Session VI


  11:30-12:00
Statistical Hypothesis Testing - Unfolding the Mystery
Oren Bar-Ilan
, Head of Non-Clinical Statistics, Teva, Israel

12:00-12:30
How many?  A question that leads to a good study design
Oren Bar-Ilan
Head of Non-Clinical Statistics, Teva, Israel

12:30
Lunch Break and visit the Exhibition

13:30
Session VII


  13:30-14:00
How to Ensure a Clinical Site is Ready for a Regulatory Audit
Shosh Friedman, RAC, FRAPS - President & CEO, ProMedoss Inc, USA

14:00-14:30
Usability Studies, Evaluating Man-Machine Interface (MMI)
Adi Ickowicz
, co-CEO and Founder - MedicSense Ltd, USA/Israel/Belgium

14:30
Coffee Break and visit the Exhibition

15:00
Session VIII

  15:00-15:30
Designing Medical Device Studies to Address Multiple Purposes – From Regulatory Submissions to Market Education
Shosh Friedman, RAC, FRAPS - President & CEO, ProMedoss Inc, USA

15:30-16:00
Professionalism of Clinical Research Associates (CRAs)
Andrea Saud Martinez, Country Manager, Avanti Pesquisas Clinicas, Brazil


 16:00  End of Congress