New Directions in Pharmacovigilance

This course provides insight into the demands that patients, providers, insurers, regulatory agencies, and the pharmaceutical industry have for greater understanding of the effectiveness and safety of drugs.It will explore how information gathered following market authorization under real world conditions of use is key to characterizing drug use, effectiveness and safety in different patient populations.
Regulators are seeking to make pharmacovigilance more sensitive and provide a quicker benefit/risk profile for diverse patient populations. This effort is motivated in part by acknowledged limitations of passive approaches based on spontaneous reporting of adverse outcomes, without consideration of therapeutic benefit.