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PHARMACOVIGILANCE DEBATE: BRAVE NEW WORLD OF DECISION SUPPORT
Session Chair(s)
Paul R. Eisenberg, MD, MPH, FACP
Senior Vice President, Medical Affairs, Chief Medical Officier
Amgen Inc., United States
Signal Detection in an EMR Healthcare Environment: Danish experience
Learning Objective : Recognize the need for new surveillace tools to perform proactive safety surveillance both at an early stage and over the lifecycle of drugs. Plan for a risk based approach to monitor the safety and safe use of new drugs.
Speaker(s)
Post-approval Safety Surveillance: FDA Perspective
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
The Good, the Bad and the Ugly of Patient Safety Data Sources
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
Harnessing the Power of Emerging Data and Technologies: Balancing qualitative and quantitative needs in safety surveillance
Andrew Bate, PHD, MA
GSK, United Kingdom
Vice President, Head of Safety Innovation and Analytics
Will Social Media Aid Decision Making in Pharmacovigilance? Look Before You Tweet
David John Lewis, PHD
Novartis Pharma Gmbh, Switzerland
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
Signal Detection in an EMR Healthcare Environment: Danish experience
Mona Vestergaard Laursen, MPHARM
Danish Medicines Agency, Denmark
Senior Advisor, Data Analytics Centre