Pharmaceutical Projects: Walking along the Risk Management Line

We manage risk so commonly (and unconsciously) in our everyday life that we tend to undervalue it. Risk management was officially introduced in the pharmaceutical world by the ICH guideline Q9 in 2005. Since then, it has been intensively used and, not infrequently, misused. Practice shows that risk assessment tools are often seen as an end in themselves, while such important things as brainstorming on the matter and getting to know the problem are underestimated. A pharmaceutical project provides a very good example of this: risk management is critical, but as there are many unknown factors, it has to be performed in a way that what really counts is understanding the problems we face. A pharmaceutical project has at least two actors, a pharmaceutical firm and an engineering company, possessing different backgrounds, and this often leads to different approaches. This may explain why risk management is not used as much as it should in pharmaceutical projects. Thus, this chapter considers a pharmaceutical project from the point of view of risk management.