Congress Program

Wednesday, 29 November

08:00

Registration and Refreshments

Plenary Hall

08:50

Congress Opening and Welcome Address
Shosh Friedman, RAC, FRAPS, President & CEO, ProMedoss, USA (Congress Chair)

09:00

Session 1: Regulatory Updates Affecting Clinical Trials I

09:00-09:30
Overview of New ISO 14155
Miguel Hernandez, Clinical Operations and Safety Manager MD-Clinicals SA, Switzerland

09:30-10:00
Clinical Trial Transparency – Where are we Heading?
Sara Furie, MSc Clinical and Regulatory Affairs Consultant, Israel

10:00-10:30
Updates by the Ministry of Health on a New Clinical Trial Process in Israel
Catherine Ela, Director, Clinical Trials Department, Ministry of Health, Israel

10:30

Coffee Break and visit the Exhibition

11:00

Session 2: Roles & Responsibilities of Clinical Trial Stakeholders

11:00-11:30
Who is Responsible for What? Sponsor vs. Investigator
Moshe Neuman, President & CEO, Bio-Medical Research Design Ltd, Israel

11:30-12:00
The Role of a Statistician Before, During and After a Clinical Trial
Anat Sakov, Director, Global Statistics, Teva Pharmaceuticals, Israel

12:00-12:30
Data Safety and Monitoring Boards: Purposes, Roles and Challenges
Arthur Weinstein, Attending Rheumatologist Emeritus, MedStar Washington Hospital Center, Clinical Professor Emeritus of Medicine, Georgetown University, Chief Medical Officer, Exagen Diagnostics, Inc., USA

12:30

Lunch Break and visit the Exhibition

13:30

Session 3: Regulatory Updates Affecting Clinical Trials II

13:30-14:00
Clinical Evaluation of Medical Devices and the Consequences of the MDR for this Process
Elisabethann Wright, Partner, Hogan Lovells, Belgium and
Fabien Roy, Counsel, Hogan Lovells, Belgium

14:00-14:30
The New EU Regulation on Clinical Trials (EU No. 536/2014) on Medicinal Products for Human Use
Olivier Lantrès, Partner, Fieldfisher, France

14:30-15:00
FDAAA 801 Requirements – ClinicalTrials.gov is Expanding
Bosmat Friedman, Head of Clinical and Regulatory Services ProMedoss, Inc, Canada

15:00

Coffee Break and visit the Exhibition

15:30

Session 4: “Patients Included” – Hearing the Patients’ Voice

15:30-16:00
FDA Patient Engagement Initiatives
Shoshana Friedman, RAC, FRAPS, President & CEO, ProMedoss, USA (Congress Chair)

16:00-16:30
Receiving Tomorrow’s Medicines Today – The Patient’s Voice
Matt Ellefson, SURVIVEiT®, USA

16:30-17:00
Reaching Patient Populations - Bringing Clinical Trials to UK Patients
Divya Chadha Manek, NIHR Clinical Research Network, UK

17:00

End of Day One

Thursday, 30 November 2017

08:00	Registration and Refreshments
	Plenary Hall
08:45	Session 5: Clinical Trials in the eEra
	08:45-09:15 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 09:15-09:45 Distributed Trials and Tribulations Danny Lieberman, Founder and CEO, flaskdata.io and Clear Clinica, Israel 09:45-10:15 Matching Clinical Trials with Patients: Global EHR Based Patient Recruitment Tigran Arzumanov, Head of Sales, Clinerion, Switzerland 10:15-10:25 Spotlight Company Presentation - Medivizor Tal Givoly, CEO and Co-Founder, Medivizor, Israel
10:30	Coffee Break and visit the Exhibition
11:00	Session 6: Best Practices for Clinical Study Operations
	11:00-11:30 Before Planning Your Next Clinical Trial Consider the Most Effective Statistical Methods to Minimize Costs Yossi Tal, Managing Director, TechnoSTAT Ltd, Israel 11:30-12:00 Golden Rules for Successful Monitoring Sara Furie, MSc Clinical and Regulatory Affairs Consultant, Israel 12:00-12:30 Optimizing Clinical Trial Performance Kenneth A. Getz, Associate Professor, Tufts University School of Medicine, USA
12:30	Lunch Break and visit the Exhibition
13:30	Session 7: Clinical Trials Challenges
	13:30-14:00 Ten Most Critical Challenges in Clinical Development and How to Handle These Without Losing Your Trial or Your Mind.... Paula (Pnina) Strauss Levy, Clinical & Regulatory Drug Development Expert, Strauss-Levy & Co, Israel 14:00-14:30 Challenges of Clinical trials in Rare Diseases - a Perspective on Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Omer Iqbal, Professor of Pathology and Ophthalmology, LOYOLA University Medical Center, USA
14:30	Coffee Break and visit the Exhibition
15:00	Session 8: Clinical Trial Statistics
	15:00-15:30 Multiplicity Issues in Clinical Trials Frederic Deutsch, Senior Biostatistician; Partner BioStats Statistical Consulting Ltd, Israel 15:30-16:00 Defining Research Objectives via Appropriate Statistical Hypotheses Lisa Deutsch, CEO BioStats Statistical Consulting Ltd, Israel
16:00	Congress Closing

08:00	Registration and Refreshments
	Plenary Hall
08:50	Congress Opening and Welcome Address Shosh Friedman, RAC, FRAPS, President & CEO, ProMedoss, USA (Congress Chair)
09:00	Session 1: Regulatory Updates Affecting Clinical Trials I
	09:00-09:30 Overview of New ISO 14155 Miguel Hernandez, Clinical Operations and Safety Manager MD-Clinicals SA, Switzerland 09:30-10:00 Clinical Trial Transparency – Where are we Heading? Sara Furie, MSc Clinical and Regulatory Affairs Consultant, Israel 10:00-10:30 Updates by the Ministry of Health on a New Clinical Trial Process in Israel Catherine Ela, Director, Clinical Trials Department, Ministry of Health, Israel
10:30	Coffee Break and visit the Exhibition
11:00	Session 2: Roles & Responsibilities of Clinical Trial Stakeholders
	11:00-11:30 Who is Responsible for What? Sponsor vs. Investigator Moshe Neuman, President & CEO, Bio-Medical Research Design Ltd, Israel 11:30-12:00 The Role of a Statistician Before, During and After a Clinical Trial Anat Sakov, Director, Global Statistics, Teva Pharmaceuticals, Israel 12:00-12:30 Data Safety and Monitoring Boards: Purposes, Roles and Challenges Arthur Weinstein, Attending Rheumatologist Emeritus, MedStar Washington Hospital Center, Clinical Professor Emeritus of Medicine, Georgetown University, Chief Medical Officer, Exagen Diagnostics, Inc., USA
12:30	Lunch Break and visit the Exhibition
13:30	Session 3: Regulatory Updates Affecting Clinical Trials II
	13:30-14:00 Clinical Evaluation of Medical Devices and the Consequences of the MDR for this Process Elisabethann Wright, Partner, Hogan Lovells, Belgium and Fabien Roy, Counsel, Hogan Lovells, Belgium 14:00-14:30 The New EU Regulation on Clinical Trials (EU No. 536/2014) on Medicinal Products for Human Use Olivier Lantrès, Partner, Fieldfisher, France 14:30-15:00 FDAAA 801 Requirements – ClinicalTrials.gov is Expanding Bosmat Friedman, Head of Clinical and Regulatory Services ProMedoss, Inc, Canada
15:00	Coffee Break and visit the Exhibition
15:30	Session 4: “Patients Included” – Hearing the Patients’ Voice
	15:30-16:00 FDA Patient Engagement Initiatives Shoshana Friedman, RAC, FRAPS, President & CEO, ProMedoss, USA (Congress Chair) 16:00-16:30 Receiving Tomorrow’s Medicines Today – The Patient’s Voice Matt Ellefson, SURVIVEiT®, USA 16:30-17:00 Reaching Patient Populations - Bringing Clinical Trials to UK Patients Divya Chadha Manek, NIHR Clinical Research Network, UK
17:00	End of Day One