and invites you to participate in
a One-day seminar

In partnership with:

March 25, 2008

Location: Lev Hakongressim building, Weizmann Science Park, Ness Ziona

With the world of clinical development constantly evolving and with an ever growing emphasize on issues such as safety and efficacy, it becomes essential to form a strategy that will increase the chances of the clinical trial's success, by a better comprehension of the regulatory demands.

This seminar focuses on the latest updates of the practical tools to learn from past clinical experience and understand the regulatory guidelines.

Professionals who design clinical trials or build strategies to comply with regulatory guidelines for data submissions will profit extensively from this seminar.

Program:

08:30-09:00 Registration
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09:00-09:10 Opening remarks
Tali Azulay, Director, Clinical Data Management
BioForum CDmC
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09:10-10:10 Session 1: The Israeli Regulator
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09:10-09:40 Yoel Lipschitz, Adv.
Deputy DG, Ministry of Health
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09:40-10:10 Regulation and the human factor in clinical trials
Noya Komissar, Adv.
Regulatory Affairs & Clinical Trials Contracts Manager
Research & Development Unit Fund For Medical Research
Rambam Medical Center, Haifa, Israel
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10:10-10:30 Coffee break
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10:30-11:50 Session 2: Clinical Aspects of Clinical Trials
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10:30-11:10 Phase I trials – success lies in the details
Dr. Kobi Atsmon, Director
Early Phase Research Center
Tel Aviv Sourasky Medical Center
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11:10-11:50 Phase II and III: the investigator's view point and the pharmacogenetic research in Israel
Dr. David Zeltser
Head of Internal Medicine D and Head of the Clinical Trial Network Services (CTNS)
Tel Aviv Sourasky Medical Center
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11:50-12:10 Coffee break
.......................................................................................................................................................................................................................................
12:10-13:30 Session 3 - Clinical Data Management
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12:10-13:10

Using validated clinical data management process and tools in clinical trials: presentation of the Clintrial™ system
Jean-Marie Aulnette & Gael Houille
Phase Forward, France

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13:10-13:30 eTrials: Get it right at the site
Tali Azulay
Director, Clinical Data Management, BioForum CDmC
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13:30-14:30 Lunch break
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14:30-16:15 Session 4: Biostatistics
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14:30-15:15 Applicable statistical methods in clinical trials – when and how
Prof. Ayala Cohen
Associate Professor
The William Davidson Faculty of Industrial Engineering and Management
Technion - Israel Institute of Technology
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15:15-15:45 The role of the statistician in the clinical development process
Dr. Joseph Levy
Senior Biostatistician, Global Biostatistics Unit
Global Clinical Professional Resources Section
Global Innovative R&D Division
TEVA Pharmaceutical Industries LTD
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15:45-16:15

Issues in the Analysis of Clinical Data
Dr. Anat Sakov
Statistical Consultant
The Tanor Group

   Who should attend

  • Clinical program personnel and managers
  • Clinical data personnel and managers
  • Clinical trial program and therapeutic area managers
  • Project managers and statisticians involved in data management and monitoring processes
  • QA personnel and managers
  • Regulatory affairs personnel and managers
  • Outsourcing managers

   Registration (mandatory)

  • Seminar fee: 650 NIS + VAT
  • BioForum clients – free of charge
  • Free participation is limited to 2 representatives per company

....................................................................................................................................................................................

Category: Clinical Forum
Duration:  1-Day Course
Hours:  8:30-16:30
Location: Lev Hakongressim, Weizmann Science Park, Ness Ziona
SKU: 08196


     Please click here for download of Acrobat Reader

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For further details and registration please contact
naama@bioforum.org.il

Weizmann Science Park, P.O.B. 4034
Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
www.Bioforumcdmc.com

 

 

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