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Schedule of Presentations:

Friday, January 18, 2008
08:30:00 Chairperson’s Welcome and Opening Remarks
08:45:00 Strategic Safety Management Throughout the Product Lifecyle
09:30:00 Safety Considerations for Adaptive Trials
10:15:00 Refreshment Break
10:30:00 How Adaptive Trial Design Can be Used to Maximize Drug Safety Information
11:15:00 Refreshment Break
11:30:00 PHASE IV RISK MANAGEMENT PROGRAMS Implementing Phase IV Risk Management Programs: Benefits and Returns Annette Stemhagen
12:15:00 Luncheon
13:30:00 VOLUME 9A COVERAGE Risk Management and Volume 9 A
14:15:00 CASE STUDY! Risk Management Plan (RMP): A European Perspective Based on Experience Gained Through a Collaborative Approach Between the US and Europe
15:00:00 Refreshment Break
15:15:00 VOLUME 9A COVERAGE Strategies for Running a Global Drug Safety Department Utilizing a Global Delivery Model
16:00:00 MANAGING DRUG SAFETY Advanced Quantitative Post-Marketing Safety Signal Analysis
16:45:00 Close of Conference
Saturday, January 19, 2008
08:45:00 Chairperson’s Welcome and Opening Remarks
09:00:00 IN-DEPTH PRE-CONFERENCE WORKSHOP Strategic Risk Management Plan Development: Utilizing Current Tools to Ensure Safety and Expedite Approvals
12:00:00 Luncheon
13:30:00 PREPARING FOR GLOBAL REGULATORY INSPECTIONS Preparation for Worldwide Regulatory Agency Safety Inspections
14:15:00 Interpreting the Guidelines on Risk Management Plans Robert G. Sharrar
15:00:00 Refreshment Break
15:15:00 REQUIREMENTS FOR MANAGING AND REPORTING ADVERSE EVENTS Management and Reporting of Adverse Events: Best Practices and Tools
16:00:00 Organization of Clinical Safety In Response to CIOMS VI
16:45:00 Close of Day One
3D Tissue Models
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