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Risk Management Activities: Background and Overview
9.30am
Registration and coffee
10am
Welcome and introduction
Eleanor Segal
Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is...
› David Lilienfeld, Chief Medical Safety Officer, Ambit Bioscience
10.45am
Current approaches to risk identification and mitigation
Eleanor Segal
Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is...
› Jeffrey Brown, Assistant Professor of Population Medicine, Department of Population Medicine, Harvard Pilgrim Health Care Institute/ Harvard Medical School
11.45am
Components of REMS/CERTS
› Hugh H. Tilson, Adjunct Professor, Public Health Leadership Program, University of North Carolina School of Public Health
12.30pm
Lunch
1.30pm
Post-authorization Studies
2pm
Components of Registries
› Hugh H. Tilson, Adjunct Professor, Public Health Leadership Program, University of North Carolina School of Public Health
2.45pm
Afternoon refreshments
3pm
Successful Risk Management: BRAIN
Carmen Bozic
Carmen Bozic MD is Senior Vice President and Global Head of Drug Safety and Risk Management at Biogen Idec. Her department is responsible for clinical trial and post marketing safety and risk management for Biogen Idec’s pipeline and marketed...
Dr. Eleanor Segal (“Ellie”) is a family physician and geriatrician who was a clinician/teacher for over 20 years before joining the pharmaceutical industry (Syntex) in 1991. A graduate of the University of Michigan Medical School, she is...