1. Introduction

Why managing risks?

No medicine is without risk and the benefits of a medicine always need to be weighed up against its risks. This balance of benefits and risks must not be left to chance - it should be effectively handled.

Not managing the risks may lead to crisis situations with harmful consequences for patient safety and public health. It may also impact negatively (due to legal and financial consequences and media scrutiny) on health authorities, healthcare professionals, pharmaceutical companies, public and private research , governments etc.

Crises such as the one with the medicine thalidomide in the 1960s have been key in the emergence of new regulations for managing the risk of all medicines.