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TOPIC 3: DIAGNOSIS OF ADVERSE DRUG REACTIONS
Session Chair(s)
Gaby L. Danan, MD, PHD
Pharmacovigilance Expert
GLD, France
Phil Tregunno
Deputy Director - Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Pharmacovigilance is first based on the medical assessment of the adverse events passively or actively collected in organised schemes. It is then essential to be able to identify consistently the nature of events and their seriousness as well as to assess causality with the suspect drug(s). This session will provide basic elements of the medical evaluation of ADRs.
Speaker(s)
Medical Evaluation of Adverse Drug Reactions
Gaby L. Danan, MD, PHD
GLD, France
Pharmacovigilance Expert