Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance provides understanding of up-to-date statistical methods applied to drug safety assessment from observational data. Postmarketing drug safety raises challenging methodological issues.

• Covers phamacovigilance using spontaneous reporting databases
• Explores statistical methods applied to drug safety assessment
• Features observational studies and provides understanding of up-to-date statistical methods

Students in biostatistics, epidemiology and professionals in clinical research and public health with interest in postmarketing pharmacovigilance and some statistical skills

Part 1. Phamacovigilance using spontaneous reporting databases
1. Spontaneous reporting systems
2. Signal detection
3. Signal analysis

Part 2. Pharmacoepidemiology using observational data
1. Health computerized databases
2. Observational studies