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Regulatory Science Forum


Session 7: Pharmacovigilance

Session Chair(s)

Helga  Gardarsdottir, PhD

Helga Gardarsdottir, PhD

  • Associate Professor
  • Utrecht University, Netherlands
Session 7: Pharmacovigilance

Speaker(s)

Florence  van Hunsel, PharmD, PhD

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
Lotte  Minnema, MPharm

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
Saad  Shakir, DrMed, MD, FFPM, FISPE, FRCP

The Quality and Robustness of Evidence used to support Regulatory Pharmacovigilance Decisions

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

  • Director
  • Drug Safety Research Unit, United Kingdom

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