OBJECTIVES

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance globally with a focus in North America such as :

1. Have an overview of the FAERS database, particularly the FDA Adverse Event Reporting System (FAERS), Access to the system, Uses of FAERS, Interpretation of statistical safety signals, Strengths of the FAERS Database and Limitations of the FAERS Database
2. Have an overview of the FDA Sentinel System, particularly on the current FDA Sentinel Monitoring System and the future FDA strategies to enhance Sentinel over the next 5 years
3. Discuss new data sources for information on medicines consumption, describe some of these new data sources through a reflection based on a couple of practical examples and critically assess some advantages and biases of these kind of studies.
4. Highlight the importance of how patients actually use medicines in the appearance of adverse drug reactions, discuss some examples showing the potentiality of analysing the characteristics of use of medicines, help you to identify potential sources of information on medicines use and discuss strengths, limitations and biases of different sources of information describing medicines use.

FAERS, database, safety signals, statistics, strengths, limitations, Sentinel System, medicines consumption, biases, ADR, FDA

MODULE PARTS

1. FDA System
2. Databases

TRAINER TEAM

Coordinator: Dr Veronique Kugener (from Takeda)

Expert(s): Josep Maria Castel, Roser Llop, Dr Dolores Rodriguez (from Universitat Autònoma de Barcelona), Prof Albert Figueras (from World Health Organization), Dr Sherael Webley (from University of Hertfordshire), Dr Maribel Salas (from Daiichi-Sankyo), Dr Abimbola Cole, Dona Ely (from Takeda), Nasop Experts Group (from ISoP's North American chapter), Dr Sepideh Habibi (from CRISPR Therapeutics).