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David Intercontinental & Dan Panorama Hotel, Tel Aviv, ISRAEL, May 27 - 29, 2008 |
Satellite Conference of ILSI - BIOMED 2008 |
Global Orientation in Conducting Clinical Trials
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Wednesday May 28, Thursday May 29, 2008
Dan Panorama Hotel, Tel-Aviv, ISRAEL
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Scientific Program |
WEDNESDAY, MAY 28, 2008 |
09:00-10:50 |
SESSION I: EARLY PHASES: PHASE I AND SAFETY
Chairperson: Dr. Kobi Atsmon,
Tel Aviv Sourasky Medical Center, Israel
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Dan Panorama – Golan Hall |
09:00-09:10 |
WELCOME AND INTRODUCTORY REMARKS |
09:10-09:35
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Early Phase Studies - The Israeli Perspective
Dr. Kobi Atsmon
Tel Aviv Sourasky Medical Center, Israel
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09:35-10:00 |
Preclinical Testing Elements Towards Clinical Trials
Dr. Yona Grunfeld
Harlan Biotech, Israel
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10:00-10:25 |
Phase I Studies- Current Thoughts
Dr. Hedva Voliovitch
Teva Pharmaceutical Industries, Israel
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10:25-10:50 |
Bioethical Aspects of Early Phase Trials in Humans
Dr. Avshalom Adam
The MBA Program, The College of Management, Israel
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10:50-11:20 |
COFFEE BREAK |
11:20-13:00 |
SESSION II: E-CLINICAL TRIALS: TECHNOLOGIES AND REGULATIONS
Chairperson: Tali Azulay,
BioForum CDmC, Israel
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Dan Panorama - Golan Hall |
11:20-11:40 |
The Changing Face of Clinical Data Management
Tali Azulay
BioForum CDmC, Israel
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11:40-12:20 |
Validation and Regulatory Compliance of eSystems for Conducting Global Clinical Trials; Providing Insight and Recommendations for Compliant Implementation of EDC in the eSystem Clinical Environment
Michael Owings
Phase Forward, USA
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12:20-13:00
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How Much Do Electronic Diaries Improve the Quality of Clinical Trials Data?
Dr. Valdo Arnera
PHT Corporation, Switzerland
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13:00-14:00 |
LUNCH BREAK |
14:00-17:00 |
SESSION III: CLINICAL TRIALS: THE BRIDGE FROM FICTION TO REALITY
Chairperson: Dr. Julian Itzcovitz, Venture Technologies, Israel
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Dan Panorama - Golan Hall |
14:00-14:30 |
Magnetic Resonance-Guided laser Interstitial Thermal Treatment of Resistant Metastatic Brain Tumors
Dr. Julian Itzcovitz
Venture Technologies, France
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14:30-15:00 |
New Directions in Brain Imaging Research & Applications
Dr. Dafna Ben Bashat
Tel Aviv Sourasky Medical Center, Israel
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15:00-16:00 |
COFFEE BREAK |
16:00-16:30 |
Convection-Enhanced Drug Delivery
Dr. Yael Mardor
Sheba Medical Center, Israel
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16:30-17:00 |
Vascular Targeted Photodynamic Therapy (VTP) of Localized Prostate Cancer-From the Lab to the Clinic
Prof. Avigdor Scherz
The Weizmann Institute of Science, Israel
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THURSDAY, MAY 29, 2008 |
09:00-10:50 |
SESSION I: PHARMACOGENETICS
Chairperson: Dr. Dan Goldstaub,
Tiltan Pharma, Israel
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Dan Panorama – Golan Hall |
09:10-09:35
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Pharmacogenetics in Current Use - Some Examples and the Lessons They Teach
Dr. Dan Goldstaub
Tiltan Pharma, Israel
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09:35-10:00 |
Pharmacogenetics and Translation Towards Personalized Medicine in Multiple Sclerosis
Prof. Ariel Miller
Department of Neurology, Carmel Medical Center, Israel
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10:00-10:25 |
The Implementation of Pharmacogenetics in the Pharmaceutical Industry
Dr. Amir Tchelet
Teva Pharmaceutical Industries, Israel
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10:25-10:50 |
Regulation of Pharmacogenetic Trials in Israel
Dr. Zelina Ben-Gershon
Ministry of Health, Israel
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10:50-11:20 |
COFFEE BREAK |
11:20-13:00 |
SESSION II: DRUG SAFETY FROM PHASE I TO SUBMISSION
Chairperson: Dr. Hedva Voliovitch,
Teva Pharmaceutical Industries, Israel
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Dan Panorama - Golan Hall |
11:20-11:40 |
The European Risk Management Plan From Clinical Trails to File Submission
Dr. Liat Flaishon
Teva Pharmaceutical Industries, Israel
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11:40-12:00 |
Research & Special Population: People With Disabilities
Prof. Avi Ohry
Reuth Medical Center, Israel
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| 12:00-12:20 |
The Ministry of Health's standpoint regarding Clinical Trials in Israel
Adv. Yoel Lipschitz
Ministry of Health, Israel |
12:20-13:00
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The Challenge of Vigilance Reports With Drugs Versus Medical Devices and Combination Products
Dr. Monica Tocchi
Meditrial, Italy |
13:00-14:00 |
LUNCH BREAK |
14:00-15:20 |
SESSION III: INFORMED CONSENT
Chairperson: Prof. Jacques Michel,
Hadassah University Medical Center, Israel
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Dan Panorama - Golan Hall |
14:00-14:20 |
Informed Consent - the Legal Perspective
Adv. Baruch Shugol
Shugol, Ketzef, Ehrlich, Kerner & Co., Israel |
14:20-14:40 |
Informed Consent – History, Present And Future - the Investigator's Perspective
Dr. Dorit Eldar
BioForum Applied Knowledge Center, Israel |
14:40-15:00 |
The Research Nurse and the Informed Consent
Shula Rabin
Tel Aviv Sourasky Medical Center, Israel |
15:00-15:20 |
Informed Consent – Ideal, Illusion or Deceit? Ethical Considerations
Prof. Jacques Michel
Hadassah University Medical Center, Israel |
15:20-15:40 |
COFFEE BREAK |
15:40-16:00 |
CONFERENCE CLOSING |
Dan Panorama - Golan Hall |
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Contact us
For further information, please contact us at:
Tali Azulay
BioForum CDmC
Phone: +(972)-8-931-3070
FAX: +(972)-8-931-3071
E-mail: talia@bioforumcdmc.com
Web site: www.bioforumcdmc.com |
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