Central Labs

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Agenda At A Glance

Agenda At A Glance

MONDAY JANUARY 26, 2009
Full Day Workshops B1- B2
B1 Overcome Outsourcing & Operational Challenges for Smaller Companies
8:00Registration and Morning Coffee hosted by3:15Afternoon Networking Break
10:30 Morning Networking Break5:15Workshop Concludes
12:30Networking Luncheon5:15- 6:45Networking Reception
B2 Getting the Most Technical Expertise from Your Labs: Biomarkers, Personalized Medicine, Diagnostics, and Assay Development
8:00Registration and Morning Coffee hosted by3:15Afternoon Networking Break
10:30Morning Networking Break5:15Workshop Concludes
12:30Networking Luncheon5:15- 6:45Networking Reception
Half Day Morning Workshops B3Half Day Afternoon Workshops B4
8:00Registration and Morning Coffee hosted by1:00Workshop Registration hosted by
9:00 Workshop Opens1:45Workshop Opens
10:30Morning Networking Break3:15Afternoon Networking Break
12:30Luncheon for Morning Workshop Delegates and Presenters5:15Workshop Concludes & Networking Reception

TUESDAY JANUARY 27, 2009
7:30Registration and Morning Coffee hosted by World courier logo10:15Morning Networking Break in Exhibit Hall
8:15Chairperson’s Welcome11:00Improve Operational Success by Developing Vendor Quality Management Plans
8:30The Changing Face of R&D: Trends in New Drug Development
Kenneth I. Kaitin, PhD, Director and Professor of Medicine, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
11:45Current and Future Metrics Champion Consortium Metrics Initiatives
9:30Drug Safety Evaluation: Benefit-Risk Assessments throughout Development and Therapy12:15-1:30Strolling Networking Luncheon in Exhibit Hall
    

1:30Track A Central Lab Relationship Development ICON Central LaboratoriesTrack B Standardization in Imaging StudiesTrack C Improving and Standardizing ECG and Cardiac Safety Studies
1:35 Improve Patient Care, Transparency and Process Efficiency in Global StudiesCurrent Standardization Initiatives for Use of Imaging in Clinical TrialsUpdate on FDA Guidance for ECG Related Studies
2:00Central Lab Cost Drivers and Logistics Discussion ForumMetrics Champion Consortium Imaging Performance Metrics AnnouncementECG Data Integration and Standardization with CDM/EDC Systems
2:30Local Lab Data Collection in Late Phase Oncology Trials for Improved Data OutcomesUtility of Imaging in Clinical Trials- Strategies for SuccessNew Equipment and Software Technology Landscape
3:00 - 3:45 Networking Break in Exhibit Hall Hosted by
3:45Best Practices for Collecting and Integrating Data in International Clinical TrialsBridging Small Imaging Studies to Large Imaging Studies for Smoother TransitionsOPEN SESSION
4:15Risk Management for Global StudiesStandardizing Intra/Inter Observer Variability and Adjudication Rates in Imaging StudiesUsing the MCC ECG Metrics
4:45Development of Central Laboratory in China-Challenges and OpportunitiesExtended SessionHot Topics and Trends in Cardiac Safety Studies
5:15 - 6:45Tuesday Concludes Reception in Exhibit Hall Hosted byTuesday Concludes Reception in Exhibit Hall Hosted byTuesday Concludes Reception in Exhibit Hall Hosted by
    

Wednesday January 28, 2009
8:15Morning Coffee11:30Sample Management: Tracking Global Lab Samples to Ensure you Get the Data
9:00Chairperson’s Recap of Day One12:00Comparing Approaches: Preferred Providers vs Competitive Bidding, What is your Best Choice?
9:15Strengthening the Sponsor / Vendor / Site Relationship. What Do Sites Really Think?12:30-1:30Networking Luncheon in Exhibit Hall
10:00Incredible Change: Overcome your Partnering Obstacles with the “Hulk” Lou Ferrigno  
10:45-
11:30
Networking Break Keynote Meet and Greet  

1:30Track A: Central Lab Relationship Development
ICON Central Laboratories
Track B Standardization in Imaging StudiesTrack C Improving and Standardizing ECG and Cardiac Safety Studies
1:35 Overview of Metrics: Definition Refinement & Update from the Central Lab MCC InitiativeCharter Development and Industry Standardization with FDA/ PhRMAWorking Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints
2:15Open SessionBuilding the Imaging Lexicon for Rate Cards to Improve Industry ConsistencyExtended Session
3:00Reducing Costs at Investigator Sites through
Process Improvement
Imaging Regulatory Environment Shift StrategiesMethods to Mitigate the Potentially Distorting Effect of Heart Rate in QT Analyses
3:30 Conference Concludes
    
             
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