The analysis of the safety profile of any medicine should weight up the consequences of a given adverse drug reaction to individual patients exposed to the medicine, as well as the impact on the community.

This course intends to bring you :

• Information relating to types of aggregate reporting in pharmacovigilance
• Knowledge of US aggregate reporting requirements

At the end of the course, you will have :

• Knowledge of aggregate reports, including Periodic Adverse Drug Experience Reports (PADERs) and Periodic Adverse Experience Reports (PAERs), as well as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs) as applicable to FDA requirements

• Knowledge of the US Regulatory Framework