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

12:30
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

12:30
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

15:00
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