| Program: |
| 08:00-09:00 |
Welcome & Registration |
| 09:00-09:30 |
Session 1
Opening Session |
Greetings by:
Dr. Ravit Geva
CTrials Chair Person, Director of the Oncology Research Unit, Sourasky Medical Center, Tel Aviv
Prof. Arnon Afek
Director General, Israeli MOH
Dr. Miron Livneh
Country Manager, Pfizer Pharmaceuticals Israel Ltd. |
| 09:30-10:00 |
Keynote Lecture:
From the Mouse Cage to the Patient's Health
Prof. Zelig Eshhar
Head of Immunological Research Center, Sourasky Medical Center, Tel Aviv
2015 Israel Prize laureate in Life Sciences Research |
| 10:00-10:30 |
Coffee Break and Exhibition |
| 10:30-12:30 |
Session 2
Pharmacogenetics
Chair Person: Dr. Dan Goldstaub
Director of Clinical Research, MSD |
Session 3
Behind The Scenes of the Investigational Product
Chair Person: Mrs. Rachel Shimonovitz
Head of the Inspectorate Institute for Standardization and Control of Pharmaceuticals, Israeli Ministry of Health |
Pharmacogenomic Research as an Integral Component of Drug Development
Dr. Rebecca Blanchard
Executive Director, Genetics and Pharmacogenomics, Head of Clinical Pharmacogenomics, Merck
USA
 |
Prof. Zvi Borochowitz
Chair Person of the Helsinki Committee for human clinical trials, Israeli MOH, Director of the Simon Winter Institute of Human Genetics, Bnai Zion Medical Center, Faculty of Medicine, Technion, Haifa
Prof. Oren Shibolet
Director of theLiver unit, Sourasky Medical Center, Tel Aviv, Faculty of Medicine, Tel Aviv University
Prof. Dror Haratz
Chair Person of the Helsinki Committee, Sheba Medical Center, Tel Hashomer
Panel Discussion
Moderator: Bilhat Azar, Adv.
Pharma Medis, Israel
Panelists:
Dr. Rebecca Blanchard
Executive Director, Genetics and Pharmacogenomics, Head of Clinical Pharmacogenomics, Merck, USA
Prof. Zvi Borochowitz
Chair Person of the Helsinki Committee for human clinical trials, Israeli MOH
Prof. Oren Shibolet
Director of theLiver unit, Sourasky Medical Center, Tel Aviv, Faculty of Medicine, Tel Aviv University
Prof. Dror Haratz
Chair Person of the Helsinki Committee, Sheba Medical Center, Tel Hashomer |
Dr. Ravit Geva
CTrials Chair Person, Director of the Oncology Research Unit, Sourasky Medical Center, Tel Aviv
Dr. Dan Goldstaub
Director of Clinical Research, MSD, Israel
Talia Agmon, Adv.
Senior Deputy to the Legal Advisor, Israeli MOH
|
|
Demand Planning for Clinical Supply
Mrs. Neta Bendelac
Head of Clinical Supply Chain IL Global Clinical Operations, Teva Pharmaceuticals Israel |
Quality of CTM: Evolving Requirements Related to Risk Assessment
Dr. Orna Dreazen
CEO and Chairperson of the Board of Directors, Nextar Ltd., Israel |
Investigational Product Labeling Mrs. Limor Teomim
Quality Assurance Director, inPACK Clinical Supply, Israel |
GDP- Good Distribution Practice During Shipping
Mr. Sharon Schnieder
Managing Director, World Courier, Israel |
Investigational Product Import for Clinical Trials– Changes in light of the New Legislation
Mr. Asi Veshler
VP,Trialog Clinical Trials Ltd, Israel |
Personalized Medicine– Shipping and Logistic Aspects of Planning and Execution
Mrs. Ilana Avhar
Customer Service Manager, World Courier, Israel |
| 12:30-12:45 |
Coffee Break and Exhibition |
| 12:45-13:30 |
Session 4
Attracting Companies to Conduct Clinical Trials in Israel
The challenge of setting-up regulatory infrastructure that encourages the competitiveness of the Israel clinical trials industry |
Opening remarks:
Rafael Torgovicky, MD
Medical & Regulatory Director, Eli Lilly, Israel
Panel Discussion
Panelists:
Mr. Amit Lang
Director General, Ministry of Economy, Israel
Michal Roll PhD,MBA
Director, Division of Research & Development, Tel Aviv Sourasky Medical Center
Mrs. Idit Chernovitz
CEO, Pharma Israel
Rafael Torgovicky, MD
Medical & Regulatory Director, Eli Lilly, Israel |
| 13:30-14:30 |
Lunch Break and Exhibition
CTrials General Assembly |
| 14:30-16:00 |
Session 5
From Basic Research to Clinical Research
Chair Person: Prof. Avishay Sella
Head, Department of Oncology
Asaf Harofeh Medical Center
|
Session 6
Risk Prevention at Clinical Sites
Chair Person: Mrs. Ayala Yogev
Head of Clinical Operations, Hoffmann-La Roche, Israel |
Session 7
The Clinical Data
Chair Person: Prof. Ron Kenett
Ph.D.,Chair Person and CEO of the KPA Group and KPA Ltd, Institute for Drug Research of the Hebrew University in Jerusalem, University of Turin, Italy |
Session 8
Additional Perspectives on Clinical Research
Chair Person: Dr. Mina Arinos
Clinical Trials Department Manager, Ministry of Health, Israel |
Begin With the End in Mind: The Target Product Profile, a Critical Component of Drug Development
Eric Lang
MD, VP, Molecule Development Group, Covance Inc, NJ, USA
|
From Site to Sponsor, How to Comply with the New EU Regulation – Parmacovigilance
Dr. Irene Fermont
IFC Ltd Director,
ISOP ISRAEL Coordinator |
A Glimpse into the Next 20 Years of Data Management
In Light of a Data Manager's Personal Journey over 2 Decades
Mr. Richard Young
Vice President Global Consulting Partners, Medidata Solutions Worldwide, UK
 |
Professional Translation of Medical Documents – TheBridge between Planning and Execution of the Trail
Dr. Dorit Eldar
Medical Director, Bioforum, Israel |
Medical Devices Clinical Trials in 2015
New Regulatory Requirements of the FDA and the European Union
Mr. Gadi Ginot
CEO, Physio-Logic Ltd, Israel |
Risk Based Monitoring
Don't be Frightened
Mrs. Michal Nevo
Recruitment Specialist, Local CPM, Quintiles, Israel |
How Can Bigdata be Used in Clinical Trials
Mr. Eyal Wulz
Managing director, Bioforum, Israel |
Ten Tips for Design and Management of a Successful Clinical Trial
Dr. Rafael Marilus
CEO, Elmar Clinical Research Management, Israel |
What Not To Do In a Clinical Trial Protocol
Mr. Ken Phelps
CEO, Camargo, Cincinnati, USA
|
Site/Sponsor Challenges
Mrs. Lihi Bodenuk
Director of Clinical Research, Hoffmann-La Roche, Israel |
Statistical Applications in Clinical Trials
Mr. Gil Harari
CEO, MediStat Ltd, Israel |
"Big Brother" and Reality Shows in Clinical Trials in Israel
Dr. Moshe Neuman
CEO, B.R.D Bio-Medical Research Design Ltd, Israel |
Autologous Cell Therapy, Clinical Development of an Autologous Cell Therapy for Critical Limb Ischemia: Building on Past Successes and Lessons Learned
Dr. Elmar Burchardt,
CEO and President of Hemostemix Inc, Canada
|
Immuno-Oncology, Trial Design, End Points and Toxicities
Naftali Bechar, MD
MD, Medical Director, Oncology Clinical Development Services, Covance, Inc
|
Informed consent or Inadvertently,
The Use of Information for Future Research
Ronya Rubinstein, Adv.
Director of R&DUnit, Rambam Medical Center, Israel |
Insurance, Clinical Trials and Everything in Between
Yaron Grinberg, Adv.
Manager of Howden Medical, Howden, Israel |
| 16:00 |
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