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safescimet course 5.2 - Clinical Safety: Post-Approval

Drug safety in human patients is the ultimate goal of drug safety scientists. Because limitations of patient populations studied during drug development and uncertainties related to potential drug-drug interactions or rare or idiosyncratic adverse reactions, it is important to pay careful attention to human safety to achieve a better understanding of the safety of drugs on the market used in a wider patient population, for long treatment duration and on various co-medication compared to the population included in the approval package. This course will provide participants with an overview of the current knowledge on the clinical assessment and follow-up of drug safety post-approval and human safety.

Key subjects addressed by the course

  • Modalities of detection, analysis and validation of drug-induced adverse events (pharmacovigilance)
  • Pharmacoepidemiology as a tool for the identification and study of drug-induced adverse events, diagnosis and management of acute drug poisonings
  • Risk minimization activities in the post-marketing phase, incl. medication errors and misuse
  • Occupational safety in workers exposed to active drug ingredients
  • Post-approval safety commitments 
  • Legal, societal and economic aspects of adverse drug reactions
  • Statistical evaluation of endpoints and measure for extrapolation
Paris, France

On-site course dates

Course leader 
Prof Marc Pallardy
Dr Henri Caplain
Dr Armelle Biola-Vidamment
Couse certificate 
Course fees 
  • Company - 2.500 EUR
  • Small and medium companies (up to 250 employees) - 1.250 EUR
  • Regulatory authorities (government) - 1.250 EUR
  • Academic institutions (universities) - 500 EUR