Satellite Conference of ILSI - BIOMED 2009

Clinical Trials Symposia

Tuesday, June 16, 2009
Hall G, Dan Panorama Hotel, Tel-Aviv

Presentations from Biomed 2009:

SAFETY ISSUES RESULTING FROM POOR TRANSLATION OF CLINICAL TRIAL DOCUMENTS
When Science Meets Regulation and Culture
Dorit Eldar, M.D., Medical Director BQT Biomedical Translations, Petach Tikva, Israel
Yehudith Wexler , Chairperson BioForum Group, Ness-Zionna, Israel

Can electronic collection of PROs increase drug safety during clinical trials?”
Real-time data collection and data access in clinical trial safety monitoring
Valdo Arnera, MD, Jill V. Platko PhD, General Manager PHT Europe

Leveraging Standardized Clinical Trial Data to Improve Safety
Wayne R. Kubick, Sr. Vice President, Lincoln Safety Group, Phase Forward, Inc.

Nuts and Bolts of Safety Reporting. The Role of the CRO
Dr. Noa Lowenton Spier, Pharma-Clinical S.A.G

Morning Session
Organized by

Afternoon Session
Organized by
From Bench to Basket;
The Winning Way to Conduct Clinical Trials
Safety in Clinical Trials

The conduct of clinical trials is becoming increasingly complex and demanding. Strict international regulations and close public scrutiny drive all parties involved in clinical trials - sponsors, investigators, regulators, coordinators – to keep a watchful eye on the evolving changes and expectations in this area.

Israel has been cultivating a very encouraging atmosphere for novel, health-related high-tech, biotech and pharmaceutical R&D projects. It is only natural that clinical research should be part of it. Indeed, Israel possesses all the basically right "ingredients" for becoming one of the leading countries in this area: highly competent investigators in all relevant clinical fields, state of the art equipment and facilities, high study recruitment rate and awareness of the need to comply with the highest international standards of operation.

The goal of this conference is to highlight topics that are of interest to those involved in clinical trials, either directly or indirectly, aiming in particular to the interactions between local and international "consumers" of this service

Safety in clinical trials means minimizing hazards, working in a secure environment, staying within your budget limits and an adequately planned program. Safety means being aware of the anticipated risks, safeguarding the welfare of your volunteers, handling data correctly and efficiently. Safety means quality and reliability.

Various aspects of safety will be presented and discussed, focusing on current approaches to tracing safety signals, electronic patient diaries and the critical role of translation of clinical trial documents.

The second session will introduce pertinent current topics including pharmacovigilance, safety in vaccine trials, and the CRO's struggle with safety issues. We will end by presenting the future direction of safety in clinical trials.

Join us at the BioMed 2009 Clinical Trial Safety Symposium and get to know more about some of the crucial elements regarding safety in clinical trials.
 

     Bioforum's Invited Speakers

Mr. Wayne Kubik
Sr. Vice President and Chief Quality Officer
Phase Forward, USA
Web site: www.phaseforward.com
Valdo Arnera, M.D.  
General Manager Europe  
PHT Corporation, Switzerland 
Web site: www.phtcorp.com
Dr. Jeanne Novak, Ph.D.
Owner and Principal Consultant
CBR International Corp
Web site: www.cbrintl.com

Scientific Program:

Morning Session Organized by GCP

09:00 - 09:05

Welcome

09:05 - 09:30

ISRAEL – the Land of Milk and Honey.
Clinical Trials Perspective

Mr. Zeev Zelig
VP, General Manager
GENZYME ITG (Israel, Turkey,Greece)
and
Chairman of the board
PHARMA ISRAEL

09:30 - 10:05

 First In Man (FIM) with Medical Devices
When considering or conducting a FIM study with medical devices:
  • Are they at all required?
  • What are their unique characteristics?
  • What needs most attention when designing, planning and conducting them?

Tami Abudi
Clinical Research Consultant,
VP, Clinical Affairs
BECKER VSG, LLC (USA)
and
Sr. Associate, Clinical Affairs
DONAWA CONSULTING (Italy)

10:05 - 10:40

Playing by the rules and strict score keeping
The discussion will focus on defining:

  • The aim of the study
  • For what purpose is the data to be used
  • Questions that the study is to answer
  • How to collect relevant and important data
  • Developing a statistical plan and data management that will be able to answer these questions.

Dr. Stephen Levenstein
VP, Research Division, GCP Clinical Studies Ltd.

Tse'ela Schwartz
CRM, Medical Devices and Biostatistics
GCP Clinical Studies Ltd.
10:40 - 11:10 Coffee Break

11:10 - 11:45

 Local teams with international players
  • Selecting and working with international CROs.
  • Israeli sites participating in multinational studies.

Karen Hill
Senior Director Project Management Worldwide Clinical Trials

11:45 - 12:05

 SOPs - A Crucial Key to Success
  • The international requirements
  • The importance of SOPs in clinical trials
  • Effective set-up, use and maintenance of SOPs

Ornat Katzir
Clinical Research Consultant

12:05 - 12:30

Legal Aspects: Complexity and Exposure

Eytan Liraz, Adv.
Eytan Liraz & Co., Law Offices
Afternoon Session Organized by Bioforum: Safety in Clinical Trials
First Session – Chairperson: Tali Azulay, VP Clinical Data Management, Bioforum CDmC
12:30 – 12:50
 Leveraging Standardized Clinical Trial Data to Improve the Detection and Understanding of Safety Issues During the Trial
Mr. Wayne Kubik
Sr. Vice President and Chief Quality Officer
Phase Forward
12:50 – 13:10
 eDiaries as a Tool for Increasing Drug Safety During Clinical Trials
 Dr. Valdo Arnera, MD
General Manager
PHT Europe
13:10-14:20
 Lunch
14:20 – 14:40
 Safety Issues Resulting from Poor Translation of Clinical Trials Documents
 Dr. Dorit Eldar, MD
Medical Director
BQT – Biomedical Quality Translations
(a partnership of QT and Bioforum)
Second Session – Chairperson: Dr. Hedva Voliovitch, VP Global Drug Safety & Pharmacovigilance, Teva
14:40 – 15:00
 From Trial to Market: Tools and Challenges in Pharmacovigilance
 Sandy Roth, Pharm.D.
Head of Safety & Pharmacovigilance
Bioforum CDmC
15:00 – 15:20
 Risks in Clinical Trials for Vaccines Dr. Jeanne Novak, Ph.D.
Owner and Principal Consultant
CBR International Corp
15:20 – 15:40
 The Nuts and Bolts of Safety Reporting - the Role of the CRO
 Dr. Noa Lowenton Spier, D.V.M
Project Manager
Pharma Clinical S.A.G.
15:40 – 16:00
 The Future of Drug Safety: Expanding the View and Narrowing the Focus
 Dr. Hedva Voliovitch, MD
VP Global Drug Safety & Pharmacovigilance,
Teva
16:00 - 16:30 Bioforum Panel Discussion: Safety in Clinical Trials

Who Should Attend:

Professionals from pharmaceutical, biotech and CROs:

  • Clinical project personnel and leaders
  • Clinical trials managers
  • Heads of clinical research
  • Clinical research associates
  • Clinical/Site monitors
  • Investigators
  • Clinical trial program and therapeutic area managers
  • QA personnel and managers
  • Regulatory affairs personnel and managers
  • Clinical operations personnel and managers
  • Clinical data personnel and managers
  • Clinical statisticians
  • Clinical IT managers
  • Clinical/Medical advisors

Registration:

For registration details see: http://www2.kenes.com/biomed/Registration/Pages/Conference_Registration.aspx

Please mention your registration to the Clinical Trials Symposia.

 

 

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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