2nd Annual Post-Approval Drug Safety Strategies Nov (13-14)
Park Hyatt Philadelphia
200 South Broad Street
Philadelphia, PA
2nd Annual Post-Approval Drug Safety Strategies best practices to mitigate risks throughout the product's life cycle.
Cambridge Healthtech Institute
Park Hyatt Philadelphia

Event Sponsors

Schedule of Presentations:

Tuesday, November 13, 2007
07:30:00 Conference Registration and Morning Coffee (07:30-08:30) George Weinstock, Michael J Owens
08:30:00 Opening Workshop and Discussion; Case Study-Based Workshop: Identifying and Managing Pharmacovigilance Risk with a Business Partner (08:30-10:30) Diana O’Connor, Joanna L. C. May, Edie Hudson
10:30:00 Morning Coffee Break (10:30-11:15)
11:15:00 Day I KEYNOTES: Structured Benefit-Risk Balance: Update on Industry Initiatives (11:15-12:00) John Ferguson
12:00:00 Day I KEYNOTES: Integrating Drug Safety Knowledge Longitudinally Across a Compound’s Lifecycle as well as Across the Organization’s Entire Product Portfolio (12:00-12:45) Judith M. Sills
12:45:00 Best Practice in Developing a Drug Safety Surveillance Program to Minimize Risk (12:45-13:15) Alan Goldberg
13:15:00 Luncheon and Strategic Solutions Presentations or Lunch on Your Own (13:15-14:30)
14:30:00 CASE STUDY: Risk Management in Early Development: The Pre-Clinical/Clinical Safety Feedback Loop (14:30-15:15) CASE STUDY Vivek Kadambi, John Ferguson
15:15:00 CASE STUDY: Successful EU Web-Based Post-Marketing Surveillance: the Actelion Experience (15:15-15:45) Eleanor S. Segal
15:45:00 Networking Refreshment Break (15:45-16:15)
16:15:00 CASE STUDY: Interpreting the Guidelines on Risk Management Plans (16:15-16:45) Robert G. Sharrar
16:45:00 SPECIAL CO-PRESENTATION: Benefits of Engaging the Research Enterprise – Methods, Signals, and Validation in a Healthcare System. (16:45-17:30) Fran Cunningham, Alexander Ommaya
17:30:00 INTERACTIVE PANEL: Costs and Opportunities of Phase IV Risk Management Programs (17:30-18:15) Gerald Faich, Jan Willem van der Velden, Daniel K. Burns, Patrick Caubel
18:15:00 Networking Reception
19:15:00 Close of Day One
Wednesday, November 14, 2007
07:45:00 Breakfast Workshop or Morning Coffee (07:45-08:15)
08:15:00 Chairperson’s Opening Remarks (08:15-08:30)
08:30:00 Day II KEYNOTES: Proactive Risk Management – Philosophy, Strategy & Tactics (08:30-09:15) J. David Haddox
09:15:00 Day II KEYNOTES: Decreasing Liability and Improving Brand by Employing a Proactive Communication and Risk-Management Strategy (09:15-09:45) Vikram Dev
09:45:00 Day II KEYNOTES: CASE STUDY - Use of Genetic Biomarkers to Reduce Risk of Drug Associated Adverse Events (09:45-10:15) Case Study Daniel K. Burns
10:15:00 Networking Coffee Break (10:15-10:45)
10:45:00 SPECIAL CO-PRESENTATION: The Other Side of the Benefit-Risk Ratio: Outcomes Research as a Means of Demonstrating Product Benefit (10:45-11:15) Peggy Schrammel, Donald B. Chalfin
11:15:00 Practical Thinking Process in Selecting Safety Studies to Support Post-Marketing Safety Surveillance and Risk Assessment: Balance Feasibility, Cost, and Scientific Rigor (11:15-11:45) Sean Zhao
11:45:00 INTERACTIVE PANEL: How Can Industry Make Drugs Safer? An Exploration of How To Improve Integration of Knowledge into Meaningful Actions (11:45-12:30) John Ferguson, Sean Zhao, Uwe Maennl, J. David Haddox, Judith M. Sills, Alan Goldberg
12:30:00 Luncheon and Strategic Solutions Presentations (12:30-13:45)
13:45:00 Signal Prioritization: A Practical Problem in Pharmacovigilance (13:45-14:15) Michael D. Blum
14:15:00 A Globally Usable Risk/Benefit Management Tool (14:15-14:45) John Parkinson
14:45:00 Networking Refreshment Break (14:45-15:15)
15:15:00 Leveraging Drug Registry Tools to Assess Safety and Performance (15:15-15:45) Annette Stemhagen
15:45:00 CASE STUDY: Drug Safety in Biologicals (15:45-16:15) Nilima Justice
16:15:00 CASE STUDY: Risk Management Approaches: RevAssist® and S.T.E.P.S. (16:15-16:45) Carmen Castaneda
16:45:00 Chairperson's Closing Remarks (16:45-17:00)
17:00:00 Executive Forum Closes
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