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Session 11 - Emerging Cross-cutting Approaches to Assessment of Drug Safety
Session Chair(s)
Robert J. Temple, MD
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
FDA, United States
This session will present ideas for novel approaches to assessment of drug safety. One relevant to the earliest stages of development—selecting lead compounds on the basis of the activity of structurally related compounds—and the other relevant to post-marketing surveillance—based on systematic data mining of electronic medical history data. This session will end with a panel discussion on how innovations get incorporated into standard practice.
Speaker(s)
Quantitative Structure-Activity Relationships (QSAR)
Naomi L Kruhlak, PhD
FDA, United States
Senior Staff Fellow, CDER
Future Role of Electronic Medical Records (EMR) Data in Postmarketing Safety Surveillance
Sandra S. Garrett, PhD
Global Record Systems, LLC, United States
Executive Chair
Panelists
John R. Senior, MD
FDA, United States
Associate Director for Science, Office of Surveillance and Epidemiology, CDER
Paul B Watkins, MD
University of North Carolina At Chapel Hill, United States
Professor; Director, Hamner-UNC Inst for Drug Safety Sciences
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
Senior Vice President
Aliza M. Thompson, MD
FDA, United States
Clinical Team Leader, Division of Cardiovascular and Renal Products, OND, CDER
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