• Safety of medicinal products for human use - principles and general framework.
  • Adverse drug reactions: mechanisms, analysis, relationships, vulnerable populations.
  • Drug interactions: epidemiology, mechanisms, detection and prevention.
  • Principles of optimal pharmacotherapy.
  • Pharmacovigilance: principles, methodologies, risk management and pharmacoepidemiology.
  • Clinical trials - bioethics of drug safety, pharmacovigilance in trial design, marketing authorization applications.
  • Regulatory framework and legislation of pharmacovigilance.