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Session 7: Pharmacovigilance
Session Chair(s)
Helga Gardarsdottir, FISPE
Professor RWD for decision making on medicines, Utrecht University, Netherlands
Session 7: Pharmacovigilance
Speaker(s)
Signals from a national spontaneous reporting system; What regulatory action do they lead to?
Florence van Hunsel, PharmD, PhD
Head Signal Detection, Netherlands Pharmacovigilance Centre Lareb, Netherlands
Do labels of drugs with the same mechanism of action describe the same adverse drug reactions? A case study on TNF-a inhibitors
Lotte Minnema, MPharm
PhD candidate/pharmacovigilance assessor, Utrecht University/Medicines Evaluation Board, Netherlands
The Quality and Robustness of Evidence used to support Regulatory Pharmacovigilance Decisions
Saad Shakir, MD, FFPM, FISPE, FRCP
Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
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