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September 9, 2008
| in partnership with: |
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Program:
| 9:00 – 9:05 |
Welcome Address
Prof. Gabriel Barbash, M.D., M.P.H.
General Director, TASMC
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| 9:05 – 9:15 |
The TASMC Experience in Clinical Trials
Dr. Michal Roll, PhD, MBA
Director of R&D Division, TASMC
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Session 1
Critical Pathways in Medical Product Development
Chairman: Prof. Marcel Topilsky, M.D.
Chairman of the Ethics ( Helsinki) Committee, TASMC |
| 09:15 – 9:40 |
Meeting the Challenge of Early Phase Trials in Israel
Dr. Jacob Atsmon, M.D.
Director, Clinical Research Center, TASMC
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| 9:45 – 10:10 |
Formulations for Preclinical Efficacy/Safety and Early Proof-of-Concept Studies:
GLP and GMP Requirements
Dr. Shimon Amselem
CEO, AminoLab Pharma IL Ltd.
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| 10:15 – 10:40 |
Preclinical Animal Research in Israel: Review and Capabilities
Dr. Tal Levin-Harrus, D.V.M.
Harlan Biotech Ltd.
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| 10:45 – 11:10 |
Global Regulatory Requirements and Expectations for GMP in Manufacture of Early Phase Clinical Trials Material
Ms. Karen Ginsbury
CEO, PCI Pharmaceutical Consulting Ltd.
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| 11:15 – 11:40 |
Coffee Break |
Session 2
eClinical and eSubmission: Regulatory Agency Expectations
Chairman: Dr. David Zeltser, M.D.
Director, Department of Internal Medicine D and Clinical Trial Network Service, TASMC |
| 11:40 – 12:05 |
Regulatory Acceptance of eSource
Ms. Tali Azulay
Director, Clinical Data Management, BioForum CDmC Ltd.
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| 12:10 – 12:50 |
Converging Healthcare with Pharmaceutical Research: The Role of Data Standards
Mr. Wayne Kubick
Sr. Vice President and Chief Quality Officer, Phase Forward Lincoln Safety Group ( USA)
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| 12:55 – 13:35 |
Global Safety Surveillance: The Electronic Submission Mandate
Dr. Stanley Garbus
Co-founder and Chief Medical Officer, Sentrx ( USA)
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| 13:40 – 14:25 |
Lunch Break |
Session 3
An Open Expert-Panel Discussion:
How to Cope with Emerging Changes in Clinical Data Handling: Leads to Israeli Companies
Chairman: Dr. Jacob Atsmon, M.D.
Director, Clinical Research Center, TASMC
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| 14:25 – 15:40 |
EXPERTS:
- Dr Mina Arinos, PhD, Head of Clinical Trials Department, MOH
- Prof. Marcel Topilsky, M.D., Chairman of the Ethics ( Helsinki) Committee, TASMC
- Dr. Yafit Stark, PhD, Vice President & Chief Clinical Officer, Teva
- Dr. David Zeltser, M.D., Director, Dep. of Internal Medicine D & Clinical Trial Network Service, TASMC
- Ms. Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Ltd.
- Dr. Shimon Amselem, CEO, AminoLab Pharma Ltd.
- Dr. Tal Levin-Harrus, D.V.M., Harlan-Biotech Ltd.
- Ms. Tali Azulay, Director, Clinical Data Management, BioForum CDmC
- Mr. Wayne Kubick, Vice President, Phase Forward ( USA)
- Dr. Stanley Garbus, Chief Medical Officer, Sentrx ( USA)
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| 15:45 – 15:50 |
Closing Remarks
Dr. Jacob Atsmon, M.D.
Director, Clinical Research Center, TASMC
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Registration
for Registration Form please click here  
For more information please contact to Rachel or Dikla:
Tel Aviv Sourasky Medical Center
Early Phase Research Center
6 Weizmann St. Tel-Aviv 64239, Isreal
Tel: +972-3-6974845, Fax: +972-3-6973935
E-mail: crc@tasmc.health.gov.il
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© All Rights Reserved 2007. Bioforumcdmc.com
P.O.B. 4034 Ness Ziona, Israel, 70400, Phone: +972-8-931-3070, Fax: +972-8-931-3071
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