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Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.


TOPIC 3: DIAGNOSIS OF ADVERSE DRUG REACTIONS. SESSION 1: Medical Evaluation of Adverse Drug Reactions

Session Chair(s)

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France
Phil  Tregunno

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • 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 some clues for the recognition of two serious events involving target organs of drug toxicity.

Speaker(s)

Gaby L. Danan, MD, PhD

Medical Evaluation of Adverse Drug Reactions

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France

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+41 61 225 51 55