safescimet course 5.2 - Clinical Safety: Post-Approval

Please note: the June course has to be postponed. New dates will be soon available!

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