08:00-09:00
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Welcome & Registration
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09:00-09:30
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Opening Session
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09:00-09:10
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Opening Remarks Dr. Ravit Geva, Chairperson, CTrials Ms. Idit Chernovitz, CEO, Pharma Israel
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Chair: Ms. Idit Chernovitz
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09:10-09:20
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Greetings Rabbi Yakov Litzman, Minister of Health
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09:20-09:30
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Research as a Driving Force of the Israeli Economy Dr. Janette Lazarovits, Deputy Head of the Life Science Department, Innovation Authority
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09:30-09:40
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A Bird's Eye View on Clinical Research Ms. Liron Zohar, Director of National Programs, Medical Technologies, Information and Research Division, Ministry of Health
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Chair: Dr. Dan Goldstaub, Clinical Research Director, MSD
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09:40-10:00
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Upgrading Quality in Clinical Trials What is the CMC (Chemistry, Manufacturing and Control) Section in Trial Submissions? Ms. Stacy Malko, Assoc. Dir, Regulatory Affairs-CMC, CMC IND/CTA Department, MSD
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10:00-10:15
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The Investigational Medicinal Product Dossier Dr. Catherine Ela, Director of the Clinical Trials Department, Ministry of Health Dr. Ofra Axelrod, Director of the Institute for Standardization and Control of Pharmaceuticals, Ministry of Health
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Chair: Dr. Moshe Neuman, President & CEO, Bio-Medical Research Design Ltd.
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10:15-10:35
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Launching the New Ministry of Health Website Prof. Eyal Schwartzberg, Head of the Pharmaceutical Department, Ministry of Health
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10:35-11:00
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Coffee Break and Exhibition
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11:00-12:30
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Plenary Session: Research in the eHealth Era Chair: Dr. Shany Blum
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11:00-11:30
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Transforming Clinical Trials with Technology Mr. Glen de Vries, President & Co-Founder, Medidata Solutions
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11:30-12:00
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Panel Discussion: Clinical Research in the eHealth Era Moderator: Dr. Shany Blum, MD PhD, Regulatory and Clinical Development Consulting
Panel participants:
Mr. Glen de Vries, Co-Founder & President, Medidata Solutions Inc. Prof. Eyal Schwartzberg, Head of The Center for Pharmaceuticals & Enforcement, Ministry of Health Dr. Dan Rapaport, CTO, MindUp Mr. Guy Winograd, CEO, Softimize Ms. Hagit Nof, COO & BD, nRollmed Ms. Shlomit Cohen Ashkenazi, Camoni - a social network on health issues Mr. Sharon Harris, CTO, Assuta Medical Centers
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Chair: Mr. Asi Veshler, Vice President, Trialog clinical Trials
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12:00-12:30 |
Nano Robots - Science (not so much ...) Fiction Dr. Tom Ran, one of the leaders of the biological computer project at the Weizmann Institute of Science
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12:30-13:30 |
Lunch |
13:30-15:00 |
Designing your Clinical Trial with a Market Access Approach Chair: Ms. Irene Guz |
Analytical Risk Based Monitoring Chair: Ms. Ayelet Levanon
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Big Data Chair: Ms. Ilana Fishman
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Advanced Drug Delivery Systems – From Macro to Micro and Nano Chair: Mr. Asi Veshler
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13:30-13:50 |
Trends in the Pharmaceutical and Healthcare Industry: How are we doing and where can we improve Mr. Eric Lang, MD VP, Global Head Clinical Drug Development Strategists, Covance Inc
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Principles of Remote Monitoring Ms. Ayelet Levanon Associate Director Global Clinical Operation, J&J
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Insights for Clinical Development From Big Data Perspective Mr. Glen de Vries Co-Founder and President, Medidata Solutions Inc.
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Good Distribution Practice in Clinical Trials Rachel Shimonovitz Head of the inspectorate Institute for Standardization and Control of Pharmaceuticals
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13:50-14:10 |
How to Create Value for Your Product (Drug/ Device) for Reimbursement by Health Authority Ms. Marissa W. Fuller, MHS Senior Director Covance Market Access Services, Inc.
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Panel Discussion: ARBM Participants: The regulator: Dr. Miriam Cohen-Kandli Clinical Trials Control Manager, Ministry of Health The Principle Investigator: Dr. Avivit Peer Director of Clinical Trials in Oncology, Rambam Health Care Campus The Chairman of the Institutional Control Body: Dr. Hadas Lamberg Director Dept. of Research, Division of Research & Development, Hadassah Medical Center The Study Coordinator: Ms. Limor Ben-Zvi Coordinator, Research Unit, Oncology, Sourasky Medical Center The CRA: Mr. Eric Kornblit Monitor and project manager, J&J
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Big Data Could Build New Drugs Faster than Any Human Trial Mr. Yigal Aviv Product manager in emerging markets, Teva
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Winners and Losers in the Medical Cannabis Industry Dr. Tamir Gado CEO, BOL Pharma
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14:10-14:30 |
Intelligent Tools to Better Access patients in Clinical Trials Ms. Irene Guz Director of Clinical Operations & Country Head Covance
Mr. Eric Lang, MD VP, Global Head Clinical Drug Development Strategists Covance Inc.
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Optimization of Patient Targeting for Clinical Trials Based on the Maccabi Healthcare Services Database Dr. Vered Eisenberg, MD, MHA Director of Clinical Research, Maccabi Healthcare Services
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Nanotherapeutics from Macro to Micro Drug Delivery & Development Dr. Michel Afargan Director of Technology Development, CTO, Nanomedicine I20 Pharma, Senior Consultant to Drug Development
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14:30-15:00 |
CTrials General Assembly |
14:30-15:30
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