Drug Safety and Pharmacovigilance

We take the mission of our Drug Safety and Pharmacovigilance department—to protect patient health by delivering medicines that are as safe as possible—very seriously. In order to ensure that our responsibilities are met to the highest degree, we monitor the safety of each one of our products throughout its entire life cycle—from initial Phase 1 clinical trials until the cessation of marketing.

Once a new drug is approved and enters the marketplace, potential safety issues may occur due to the increased number of patients using the drug. The Drug Safety and Pharmacovigilance department collects, analyses, and reports to regulatory agencies all serious and nonserious adverse events that occur in drugs marketed within the territory of Astellas Europe.

In addition, the Drug Safety and Pharmacovigilance department also has detailed protocols designed to allow us to act quickly in case a serious adverse event is discovered.