Congress Program

Monday 25 June 2018

 

08:00

Registration 

09:00-09:10

Congress Opening 
Welcome Address 
Shoshana Friedman
ProMedoss, USA

09:10-10:40

Session 1: 
Clinical Trial Types and Tips

09:10-09:35

Early Phase Trials and Pivotal Trials in Pharma and Devices: Similarities and Differences
Yossi Tal, Managing Director, TechnoSTAT, Israel 

09:35-10:00

Planning a Clinical Study for the Small Startup, Tips and Hurdles
Sharon Goldfarb,
CEO, SGConsulting, Israel

10:00-10:25

Increase the Appeal of your Initiation Presentation
Chen Sirkis, CaDenSee, Israel

 
10:25-10:40

Discussion

10:40-11:10

Coffee Break and Visit the Exhibition

11:10-12:15

Session 2:  
Innovations & Technology in Clinical Trial Design

11:10-11:35

Clinical Trial Budget Negotiation and Staffing within our New Technology World
Theresa Laneve, Director of Clinical Trials, PAB Clinical Research, USA

11:35-12:00

Managing Risk in Clinical Trials: The Case for Adaptive Design Methods
Yossi TalManaging Director, TechnoSTAT Ltd, Israel 

 
12:00-12:15

 
Discussion

12:15-13:30

 Lunch Break and visit the Exhibition

13:30-15:00

Session 3
Effective Management of Clinical Trials

13:30-13:55

Site Management: Optimize Site Performance with a Successful Partnership with your CRC
Hubert Lesur
, President & Clinical Research Coordinator HL Health Support (HLHS), France

 
13:55-14:20

Project Management & Planning for Successful Clinical Trials
Daniele Zago, Meditrial Europe Ltd, Italy

 
14:20-14:45

Tips and Tricks for Effective Clinical Monitoring and Safety Oversight
Matthias Lendner, Senior CRA, Meditrial GmbH, Germany

 
14:45-15:00


Discussion

15:00-15:30

Coffee Break and visit the Exhibition

 15:30-16:30

Session 4: 
Real World vs. Clinical Trial Data

15:30-15:55

Making Real-World Clinical Trials a Reality
Martin Gibson
, Chief Executive of Northwest EHealth, Director of the NIHR Clinical Research for Greater Manchester, UK

15:55-16:20 

Meaningful Integration of Data Analytics and Services – The MIDAS Project
Paul Carlin, Work Package Lead, Ethics and Governance, MIDAS Project, UK


16:20-16:30

Discussion 

16:30

End of Day One

Tuesday 26 June 2018

 08:30-16:30

Registration 

09:00-10:30

Session 5: 
Present and Future of Patient Engagement in Clinical Trials

09:00-09:25

Possibilities of Patient Education on Clinical Research during Patient Recruitment in a Trial
Suzanne PozsonyiPatient Enrolment Specialist, SynCon International, The Netherlands

 
09:25-09:55

Strategies to Enhance Patient Compliance
Sharon Goldfarb, CEO, SGConsulting, Israel


09:55-10:20

Engagement of Patient Groups in Clinical Trials
Shoshana Friedman
ProMedoss, USA

 
10:20-10:30

 
Spotlight Company Presentation:
Role of a Medium Size CRO such as 3S-PHARMACOLOGICAL in a More and More Challenging Clinical Research Environment, Dominated by Two Extremes: Big CRO and Freelancers

Luigi Silvestro, 3S Pharmacological Consultation & Research GmbH, Germany

10:30-11:00

 Coffee Break and visit the Exhibition

11:00-12:30

Session 6:  
Assimilating Quality into Clinical Trials


11:00-11:25

Lean Six Sigma for Clinical Trials Excellence and Regulation
Sunil Aggarwal, Professor & Imaging Trials and Clinical Research Director at All Saints University, USA

 
11:25-11:50

Integrated Compliant Research Programs
Corilynn B Hughes, Oncology Research Program Manager, Clinical Manager, LifeBridge Health System, USA 

 
11:50-12:15
 
Building Quality into Clinical Trials
Shoshana Friedman
ProMedoss, USA

 
12:15-12:30
 
Discussion

12:30-13:30

 Lunch Break and visit the Exhibition

13:30-15:00

Session 7:  
Challenges and Ethics in Clinical Trials


13:30-13:55

Key Considerations and Challenges of EDC in the Implementation and Statistics of Clinical Trials
Liora Bosch, 
Biostatistician and EDC Expert, Omrix a J&J Company, Israel

 
13:55-14:20

 
Intention-to-Treat Analysis: To Modify or Not to Modify
Nesil Coskunfirat, Associate Professor at Akdeniz University Hospital, Department of Anesthesiology and Reanimation, Antalya, Turkey

 
14:20-14:45

 
Triggered or Routine Site Monitoring Visits for Randomised Controlled Trials: Results of TEMPER, a Prospective, Matched-Pair Study
William Cragg
Research Associate, Trial Conduct Methodology - Medical Research Council Clinical Trials Unit, University College London, UK


14:45-15:00

 
Discussion

15:00-15:30

 Coffee Break and visit the Exhibition

 15:30-16:30

Session 8:  
Misconduct and Fraud in Clinical Trials

 15:30-15:55

Examples and Tips on How to Detect Misconduct and Fraud in a Clinical Trial
Liora Bosch, Biostatistician and EDC Expert, Omrix a J&J Company, Israel

 
15:55-16:20
 
Misconduct and Fraud in Clinical Trials: Legal Perspectives
Olivier Lantrès, Partner, Fieldfisher, France  

 
16:20-16:30

 
Discussion

16:30

Congress Closing