BioForum CDmC is proud to launch its partnership
with Oracle Health Sciences Global Business Unit
and invite you to one-day conference

Innovative Solutions for Efficient Clinical Trials
and Safety Management

September 09, 2009 from 8:30 am to 4PM
Location: Lev Hakongressim, Weizmann Science Park, Ness Ziona

Goals

• Hear from key opinions leaders
• Share recent results obtained by companies in the sector
• Discover new and innovative solutions
• Network with your peers from the industry

 

Agenda

08:30-09:15	Registration & Coffee
09:15-09:30	Opening: Tali Azulay, VP Clinical Data Management, BioForum CDmC Rohit Mistry, Application Sales Representative, Oracle Health Sciences Global Business Unit EMEA, Spain
09:30-11:00	Session 1: Pharmacovigilance and Safety
09:30-10:30	Risk Management Plan: a new approach for pharmacovigilance requirements in Europe and USA Irene Fermont, MD, MSc, Vice President, Pharmacovigilance & Risk Management, Advanced Drug Development Services, France
10:30-11:00	Presenting Oracle adverse events reporting system (AERS) Gilbert Bellachen, Strategic Customer Programs Director, Oracle Health Sciences Global Business Unit, France
11:00-11:45	Coffee break
11:45-13:00	Session 2: Remote Data Entry
11:45-12:15	From paper to EDC: Practical considerations Tali Azulay, VP Clinical Data Management, BioForum CDmC
12:15-12:45	Presenting Oracle remote data capture Rohit Mistry, Application Sales Representative, Oracle Health Sciences Global Business Unit EMEA, Spain
12:45-13:15	The advantages of using an EDC system: Benefits at Teva Yoav Grinstein, Head of Global Clinical Data Management Systems, Teva Pharmaceutical Industries
13:15-14:30	Lunch break
14:30-16:00	Session 3: Clinical Trial Management
14:30-15:00	Project management best practices and metrics Eyal Wulz, Head of Clinical IT & BPO, BioForum CDmC
15:00-15:30	Presenting Oracle’s Siebel clinical trial management system Guy Shina, CTMS Solution Analysts, ExScientia
15:30-16:00	Streamlining clinical trials with Oracle’s siebel clinical trial management system Ido Margalit, Information and Operational Infrastructures Manager, Teva Pharmaceuticals Industries

*Agenda is subject to change

Who Should Attend?

• Project managers in clinical development
• Clinical program people and managers
• Clinical data people and managers
• Clinical trial program and therapeutic area managers
• Project managers and statisticians involved in data management and monitoring processes
• QA people and managers
• Regulatory Affairs people and managers
• Outsourcing managers
• Pharmacovigilance and safety people
• Pharma and medical devices companies

Registration

• Free of charge
• Participation is limited to 2 representatives per company
• Registration is mandatory

For Registration Form please click here

For registration please contact Naama@bioforum.co.il

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About Oracle Health Sciences
Oracle is a leading strategic software solutions provider to the health sciences industry. Oracle Health Sciences helps pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and services that deliver the most compelling customer and shareholder value. Addressing industry requirements, Oracle provides comprehensive solutions including clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance, and healthcare interoperability. Oracle partners with health sciences industry leaders – including 20 of the top 20 life sciences companies and 10 of the top 12 Fortune Global 500 healthcare organizations – to prevent and cure disease and enhance quality of life and accelerate insights for better health.
Oracle has been ranked as the number one vendor for enterprise life sciences software applications by IDC Health Insights, an advisory services and market research firm focused on the healthcare and life science markets.

For more information about our solutions and customers, please visit our website at www.oracle.com and then click on Health Sciences, or call Rohit Mistry, Sales Manager, at +34 934953342 or Bertrand Le Bourgeois, EMEA Marketing Director at  +33 157602000  or bertrand.le.bourgeois@oracle.com

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About BioForum
With more than a decade of experience, BioForum integrates basic research, applied knowledge and regulatory understanding, and has become a center of expertise which is used to form bridges between industry, academia and government agencies by enabling open channels of discussion and the flow of ideas.
Utilizing state of the art technologies and building on decades of combined experience, BioForum CDmC offers a complete range of clinical data management services for the pharmaceutical, biotechnology and medical device industries.
The company supports both paper data entry and Electronic Data capture (EDC) systems, and can recommend the best solution for your needs based on your study design, requirements and budget.
We use GCDMP (Good Clinical Data Management Practice), the industry standard for clinical data management, as a guide for performing our services, which are also fully compliant with GCP and other local regulatory standards.

For more information about our services, please visit our website at www.bioforum.co.il, or call Tali Azulay, at 08 931 3070 or talia@bioforumcdmc.com