Agenda

Day One - 4/28/2009 : AM | PM
Day Two - 4/29/2009 : AM | PM
DAY ONE - Tuesday, April 28
8:15-8:30 Chairperson's Opening Remarks
Richard Gliklich, MD, Harvard Medical School, and Outcome
Post-Approval: The New Playing Field
8:30-9:15

Keynote Address: An Update on FDAAA One Year Later
Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

9:15-10:00 Addressing the Need for More Real-World Data
Ellen Strahlman, MD, MHsc, Senior Vice President and Chief Medical Officer, GlaxoSmithKline

Managing Safety from Surveillance to REMS
10:00-10:15 Break
10:15-11:00 Risk Management Initiatives in Europe
Stella Blackburn, MD, Risk Management Coordinator, Pharmacovigilance and Post-Authorisation Safety and Efficacy, European Medicines Agency (EMEA)
11:00-11:30 Case Presentation: Nplate REMS
Rekha Garg, MD, MS, Executive Director, Global Regulatory Affairs and Safety, Amgen, Inc. 
11:30-11:45 Discussions
11:45-12:45
 Lunch
12:45-1:15 Case Presentation
1:15-2:00

A Pharmaceutical Perspective: The Impact and Challenges of Meeting New Risk Management Requirements
Douglas Greene, MD, Senior Vice President and Chief Medical Officer, Sanofi-Aventis

2:00-2:15 Break
2:15-3:00
 Sentinel Initative Case Examples
Melissa A. Robb, Senior Program Manager, Office of Critical Path Programs, Food and Drug Administration (FDA)
3:00-3:45 Challenges and Opportunities with Adjusting to the New Safety Paradigm
3:45-4:30 Starting, Stopping, and Interpreting Safety Studies Kenneth J. Rothman, DrPH, DMD, Professor of Epidemiology, Boston University School of Public Health and Vice President Epidemiology Research, RTI Health Solutions
4:30-5:15 Drug Safety: A Historical and Business Perspective Arthur Daemmrich, PhD, Assistant Professor Business Administration, Harvard Business School
5:15-5:45

Case Presentation: Global Surveillance for Public Health
Michael Peng, Associate Director Drug Safety, Roche 
Nancy Dreyer, PhD, MPH, Chief of Scientific Affairs and Senior Vice President, Outcome

6:00

Opening Night Reception
Isabella Stewart Gardner Museum

Attendees are invited to attend the opening night reception at the Isabella Stewart Gardner Museum on April 28 following the close of sessions. The reception offers attendees the opportunity to see this beautiful, world-renowned museum while networking with colleagues, speakers, and other attendees. Hors d'oeuvres, beverages, and musical entertainment will be provided and all galleries will be open to view, with docents onsite to answer any questions on the art or history of the museum.

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DAY TWO - Wednesday, April 29
8:00-8:15 Chairperson's Opening Remarks
Richard Gliklich, MD, Harvard Medical School, and Outcome
Measuring Effectiveness: Real-World Data and Comparative Effectiveness
8:15-9:00 Political and Economic Forces Driving the Development of a Comparative Effectiveness Institute
Gail Wilensky, PhD, Senior Fellow, Project HOPE
9:00-9:45 Evidence-Based Data and Decision Making in the UK
Professor Sir Michael Rawlins, MD, FRCP, FMedSci, Chairman, National Institute for Health and Clinical Excellence (NICE)
9:45-10:00 Break
10:00-10:30     Case Presentation
10:30-11:15 Implementing Evidence-Based Decision Making in the US
Carolyn Clancy, MD, Director, Agency for Healthcare Research and Quality (AHRQ)
11:15-11:35 An Industry Perspective: Challenges and Benefits of Conducting CE Research
11:35-12:35 Lunch
12:35-1:20 Evaluating Evidence for Formulary Decision-Making
1:20-2:05

Developing Evidence for Reimbusement
Sean Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy

2:05-2:15 Break

Practical Issues with Real-World Studies

2:15-3:00 Practical Issues in Designing and implementing Registries
Nancy Dreyer, PhD, MPH, Senior Vice President and Chief Medical Officer, Outcome
3:00-3:30 Case Presentation: Using a Registry for Reimbursement in Australia
John Yee, MD, MPH, Vice President Global Medical Affairs, LSD, Genzyme
3:30-4:00 Case Presentation: Using a Registry for Reimbursement in Europe
Gilbert L'Italien, Group Director, Global Epidemiology and Outcomes Research, Bristol-Myers Squibb

 

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