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Government Day 2003

Agenda

BENEFIT THE PATIENT; MANAGE THE RISK

CERTs Risk Series Strategic Symposium

March 5, 2003
Natcher, Conference Center, Bethesda, Maryland

Objectives

• To launch the research and education agenda from the five Risk Series Think Tanks
• To refine the research agenda and expand commitments to adopt specific research areas
• To discuss the Risk Series research agenda, establish priorities, and delineate next steps
• To share and receive information with agencies and organizations on their programs affecting the management of therapeutic risk

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Program

9:00 Welcome, Introductions and Program Overview

• Hugh H. Tilson, MD, DrPH, Chair
  CERTs Steering Committee
• Robert M. Califf, MD, Principal Investigator
  CERTs Coordinating Center
• Carolyn M. Clancy, MD, Director
  Agency for Healthcare Research and Quality (AHRQ)

9:10 NIH Perspective

• Belinda Seto, PhD, Acting Deputy Director for Extramural Research
  Office of the Director, National Institutes of Health

9:20 US FDA Perspective

• Robert J. Temple, MD, Director
  Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration
  

9:30 Highlights of the Risk Series Think Tanks: Risk Communication

• William H. Campbell, PhD, Principal Investigator
  University of North Carolina CERTs
• Lynn A. Bosco, MD, MPH, Director
  Pharmaceutical Studies
  Center for Outcomes and Effectiveness Research, AHRQ

9:40 Risk Assessment

• Brian L. Strom, MD, MPH, Principal Investigator
  University of Pennsylvania CERTs
• Miles Braun, MD, MPH, Director
  Division of Epidemiology
  Center for Biologics Evaluation & Research
  US Food and Drug Administration

9:50 Benefit Assessment

• Robert M. Califf, MD, Principal Investigator
  CERTs Coordinating Center
• Robert J. Temple, MD, Director
  Office of Medical Policy, Center for Drug Evaluation and Research
  US Food and Drug Administration

10:00 Risk Communication and Media

• Robert M. Califf, MD, Principal Investigator
  CERTs Coordinating Center
• Felicia E. Mebane, PhD, Assistant Professor
  University of North Carolina School of Public Health

10:10 Risk Management

• Judith M. Kramer, MD, MS, Principal Investigator
  Duke University CERTs
• Paul J. Seligman, MD, MPH, Director
  Office of Pharmacoepidemiology and Statistical Science
  Center for Drug Evaluation and Research, US Food and Drug Administration

10:20 Managing Risk Through Collaboration

• James G. Kotsanos, MD, MS, Director
  Worldwide Pharmacovigilance and Epidemiology
  Eli Lilly & Company

10:30 Break

10:50 Clinical Research Roundtable Report

• Enriqueta Bond, PhD, Chair
  Clinical Research Roundtable
  Institute of Medicine

11:05 Roundtable Discussion: Roles of government agencies and programs in determining risks and benefits of commonly-used therapeutics

• Robert M. Califf, MD, Principal Investigator
  CERTs Coordinating Center
• Carolyn M. Clancy, MD, Director
  Agency for Healthcare Research and Quality

12:20 Closing Remarks

• Hugh H. Tilson, MD, DrPH Chair
  CERTs Steering Committee

12:30pm Adjourn

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