Third Annual Post-Approval Drug Safety Strategies: Best Practices to Mitigate Risks throughout the Product's Life Cycle
The Ritz-Carlton Pentagon City
1250 South Hayes Street
Arlington, VA

Schedule of Presentations:

Wednesday, November 12, 2008
07:30:00 Registration and Morning Coffee
08:15:00 Organizer’s Welcome and Chairperson’s Opening Remarks Micah Lieberman
10:20:00 Networking Coffee Break
10:55:00 Chairperson’s Remarks John Ferguson
11:00:00 Problem Oriented Safety Evaluation through the Life Cycle Joanna F Haas
11:30:00 Genomics Role in Safety: Moving from Observation to Prediction & Leveraging New Tools and Thinking Dan Burns
12:00:00 Sponsored Luncheon Workshop (Sponsorships available, please contact Arnie Wolfson +1.781.972.5431,
13:45:00 Challenging Organizational Structure and Current Thinking in Drug Safety: Taking a Holistic Approach to Data and Departments Milbhor D'Silva
14:15:00 Optimizing the Allocation of an Organization's Drug Safety Assessment Resources Jill Robinson
14:45:00 Networking Refreshment Break
15:45:00 Risk Management as Prerequisite for Commercial Success: It's Time for a Chief Safety Officer Nayan T. Nanavati
16:15:00 Global Product Risk Management Planning: Organizational Process, Structure and Governance for Getting ‘All Hands on Board’ Susan Rosenberg
16:45:00 The Cooperative Roles of Safety Science, Clinical Safety and Marketing in Risk Management Program Jack A. Reynolds,
17:30:00 Networking Cocktail Reception
18:30:00 Close of Day One
Thursday, November 13, 2008
08:15:00 Morning Coffee (Breakfast Workshop Sponsorship Available)
08:40:00 Chairperson’s Opening Remarks Sean Darcy
08:45:00 Effectively Working with Data and Safety Monitoring Boards (DSMBs) to Ensure Patient Safety and Study Integrity Sean Darcy
09:30:00 Participating as a DSMB Member: Challenges and Responsibilities Yola Moride
10:00:00 Networking Coffee Break
10:45:00 Proactive Risk Communication as Key to Public Health and Pharmaceutical Risk Benefit Management Strategy Cherif Benattia
11:15:00 CASE STUDY of TYSABRI: RiskMAP Development and Implementation Carmen Bozic
11:45:00 Sponsored Luncheon Workshop or Lunch on Your Own
13:30:00 Chairperson’s Remarks Jan Willem van der Velden
13:45:00 Data Mining and Beyond: The Integration of Qualitative and Quantitative Pharmacovigilance Methods Michael D. Blum
14:15:00 Improving Pharmacovigilance through Active Surveillance: Opportunities and Challenges Robert F Reynolds
14:45:00 Networking Refreshment Break
15:30:00 CASE STUDY: Disease Management Programs as a Tool for Risk Management Yola Moride
16:00:00 Transforming Health Plan Assets into an Environment for Clinical Evidence Generation: The Wellpoint Safety Sentinel System Marcus D. Wilson
16:30:00 Table 2. Outsourcing Post Approval-Drug Safety Jill Robinson
16:30:00 Table 9. Identifying and Managing Pharmacovigilance Risk with Alliance Partners Ashraf Youssef
16:30:00 Table 10. Organizational Structure (Operations) in Pharmaceutical Companies for Drug Safety and Risk Management Cathy Sigler
16:30:00 Table 3. Managing DMC Processes for Maximal Independence Catherine A. Tyner
16:30:00 Table 4. Choice of Databases for Safety Surveillance Michael D. Blum
16:30:00 Table 11. The Use of Post Marketing Surveillance Data (e.g., spontaneous reports) to Fulfill Risk Management Obligations Robert Bader
16:30:00 Roundtable Discussions:
16:30:00 Table 5. Marketing and Drug Safety: Enemies or Allies Jan Willem van der Velden
16:30:00 Table 6. Costs and Opportunities of Phase IV Risk Management Programs Nayan T. Nanavati
16:30:00 Table 1. Evaluation of Risk Minimization Interventions Yola Moride
16:30:00 Table 7. Expanded Access Programs Joanna F Haas
16:30:00 Table 8. Drug Interaction Programs
17:30:00 Close of Day Two
Friday, November 14, 2008
07:45:00 Morning Coffee (Breakfast Workshop Sponsorship Available)
08:15:00 Chairperson’s Opening Remarks and Roundtable Report Outs Jill Robinson
09:00:00 Plotting a Strategy for the Best Benefit-Risk Ratio John Ferguson
09:30:00 Endpoint Trials as a Risk Management Tool Peggy Schrammel
10:00:00 Establishing Best Practices in Evaluating, Planning and Executing “Fit-for-Purpose” Benefit/Risk Management Programs for the 21st Century Bjorn Olsen
10:30:00 Networking Coffee Break
11:00:00 Drug Benefit-Risk Evidence, Assessment and Decision-Making Across Life-Cycle: Health Canada Perspective and Proposal
11:30:00 Challenges in Benefit-Risk Evaluations during Global Development and in Partnerships and Alliances Ashraf Youssef
12:00:00 New Presentation
12:00:00 Sponsored Luncheon Workshop or Lunch on Your Own
13:25:00 Chairperson’s Opening Remarks Federico Goodsaid
13:30:00 Safety Sciences - How Far Have We Come and Where are We Heading?
14:00:00 An Industry Update: The Impact of the FDAAA and Recent Updates on Risk Management Practices Objectives: Annette Stemhagen
14:30:00 Translational Safety Biomarkers and the Path to Phase-1 Studies Federico Goodsaid
15:00:00 Take Home Message and Discussion: The Need for Change Management within the Arena of Drug Safety and Pharmacovigilance, by Drug Safety Change Agents Milbhor D'Silva
16:00:00 Closing Comments
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