Farmakovigilance léčiv

The objective of my Bachelor thesis is to analyse development of pharmacovigilance and adverse event reporting in the Czech Republic and other countries, with a focus on the changes in the number of adverse event reports over the last thirty years in Czech Republic and comparison with development of adverse event reports in other countries and prediction the possible trends in adverse event reporting in the future. My Bachelor thesis will also contain definitions of adverse events in accordance with the Medicinal Products Act No. 378/2007, as well as a detailed description of the adverse event reporting procedure, the persons who are obliged to report adverse events, and the systems in place for reporting adverse events by pharmaceutical companies. I will also include a chapter on the history of pharmacovigilance in the Czech Republic and in other countries and a description of how the Uppsala Monitoring Centre, WHO's centre for monitoring adverse events, works. A section will be dedicated to pharmacovigilance tools used by State Institute for Drug Control, with a detailed focus on selected side effects of drugs reported in the recent years. In the final chapter of my Bachelor thesis, I will map the development of the number of adverse event reports in the Czech Republic and in the other countries with the aim of predicting potential trends in adverse event reporting in the future.