Scientific Program

Wednesday, 21 September

07:30  Registration 
08:50 Congress Opening

Welcome Address

Adi Ickowicz, MedicSense, Israel

 09:00 Session I:

Globalization of Clinical Trials: Mutual Recognition of Clinical Study Results
Annet MuetstegeApplied Clinical Services BV, The Netherlands

Harnessing the Power of a National Network to Deliver your Clinical Trials
Divya Chadha ManekNIHR Clinical Research Network, UK

How the use of Technology and Pre-defined Quality Methodology can help Remove Subjectivity and Ambiguity from the Translation Process
Nadège Young
, Argos Multilingual, Poland/USA

10:30  Coffee Break and visit the Exhibition
11:00 Session II:  

On The Significance of Statistical Significance
Oren Bar Ilan, Teva, Israel

FDA regulatory requirements for clinical trials conducted in the US, including First in Human and Early Feasibility Studies
Kristy Katzenmeyer-Pleuss,
NAMSA, Germany

Start up Nation: Israel as a Preferred Location for Clinical Trials
Adi Ickowicz, MedicSense, Israel

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

13:30 Session III: 

New Regulations on Notified Bodies and Conformity Assessment of High-Risk Medical Devices in Europe: Impact on Clinical Investigation from an Industry Perspective

Wenche GrønnvoldLink Medical Research AS, Norway

Clinical Evaluation and the new MEDDEV 2.7.1/rev 4
Anna PietersmaQserve Group, The Netherlands

Devices and Clinical Trials: A UK Perspective
Ravi Chana, NIHR, UK

15:00  Coffee Break and visit the Exhibition
15:30 Session IV: 

Clinical Development of Medical Devices in Turkey: Regulations and Current Status

Nursah Cetinkaya
Board Member, Clinical Research Association of Turkey, Turkey

Undiscovered Land of Clinical Trials – Poland as a Growing Market for Medical Devices

Izabela KozdraƛBrillance Sp. z o.o, Poland

When and How is it Necessary to Run a Clinical Trial for a Device in Australia?
Roy HardmanRight Time Business Pty LTD, Australia

Thursday, 22 September

08:00  Registration 
09:00 Session V: 

The Million Dollar Question – When is a Clinical Study Needed?
Celina Wang, NAMSA, Germany

The New China GCP and How to Follow it in a Clinical Trial
Chao Xu, Oamunda, China/Germany

Transparency in Clinical Research: Turkey and the Middle East
Nursah CetinkayaBoard Member, Clinical Research Association of Turkey, Turkey

10:30 Coffee Break and visit the Exhibition
11:00 Session VI:

How to do a Clinical Trial in China – Regulation and Operation Introduction
Amber Fang, NAMSA, China 

Clinical Trials for Medical Devices In India
Vivek TiwariBoston Ivy , India

Brazil: New regulations of clinical trials with medical devices – How we beneficiate of it?
Andrea Saud MartinezAvanti Pesquisa Clínica, Brazil

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

14:00 Session VII:  

Key Performance Indicators (KPIs) and Key Risk Indicators (KRI) for a clinical trial of medical device : study design and clinical operations perspective
Vivek Tiwari, Boston Ivy , India

Improving participants experience for improved compliance in clinical trials, while complying with new regulations on data privacy
Jon Ingi Bergsteinson
MEDEI ApS, Denmark

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

15:30 Session VIII:

Latin America Medical Device Regulations, Clinical Trials and Opportunities to be Explored
Andrea Saud Martinez,  Avanti Pesquisa Clínica, Brazil 

The Intricacies of Placing a Device on the Register of Therapeutic Goods in Australia

Roy Hardman, Right Time Business Pty LTD, Australia

Congress Closing