Pharmacovigilance and Pharmacoepidemiology (Master Year 1)

Course Structure

1. To understand the basic concepts and principles in epidemiology
2. To become familiar with the epidemiological tools that could be used in pharmacovigilance and pharmacoepidemiology
3. To understand the specificity of epidemiological tools applied to pharmacovigilance and pharmacoepidemiology
4. To understand applications of probability in statistics
5. To understand how to organize and describe epidemiological data
6. To understand how to perform data estimations, comparisons and predictions
7. To understand how to estimate the sample size and power of epidemiology studies
8. To introduce the principles of multivariable comparisons
9. To become familiar with the different tools that could be used in pharmacovigilance and pharmacoepidemiology research implementation
10. To become familiar with the principles of scientific communication
11. To understand the role of medicines in therapeutics, health services and society
12. To become familiar with the life cycle of medicines and the regulatory aspects of medicines market
13. To review the clinical and pharmacological basis of prescribing
14. To understand the need to evaluate the effects of medicines from an epidemiological perspective
15. To understand the relevance of unbiased information to ensure the appropriate use of medicines
16. To discuss the need to monitor medicines prescribing process
17. To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-marketing environment and the roles of various stakeholders within pharmacovigilance.
18. To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use
19. To know the main methodological and ethical characteristics and limitations of randomized clinical trials
20. To understand the differences between efficacy and effectiveness
21. To know the basic concepts and classification of the pharmacoepidemiological studies designed to evaluate therapeutic interventions
22. To identify information gaps in selected therapeutic areas (e.g. cardiovascular, psychiatry, diabetes care)
23. To know the basic principles of communication and to gain an insight into the characteristics of effective communication
24. To face to the complexity communication on risk for health
25. To know the evolution of medicine risk communication