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