3. General risk management approach and associated tools

3.1 Evolution of the concept of risk management in the pharmaceutical industry

The importance of the potential consequences of a risk - in terms of health, the environment, image and financial impact - led pharmaceutical companies to set up risk management systems at a very early stage. Various health crises have also prompted the authorities (FDA, EMA) to impose more general requirements for better control of risks associated with drugs and medical devices (distilbene, growth hormone, isomeride, contaminated blood, mediator, Vioxx®, Celebrex®, influenza, PIP implants, etc.), and have acted as a gas pedal in imposing new regulations.

While the original functions of these systems made it possible to start addressing risks, it soon became clear that it was essential...