Synthèse

Abstract

The risk management is applied on numerous occasions each and every day and can cover many different circumstances. Some decisions are taken purely on basic instinct reflecting the need for human survival yet others are made intuitively, based on experience gained, and then there are also those measured decisions taken following serious reflection. The pharmaceutical industry discovered the risk management somewhat later than other industries with the inspiration originating from ICH working groups during 2002 and 2003. Facing our undertaking to protect the health of the Public, the industry faced numerous questions such as how to explain difficult problems when public health is in question, how to sustain a decision, how to share this decision, how to develop a technical and scientific rational to support this decision? In the pharmaceutical environment on a world level, we can identify the 80s with the concept of validation, the 90s with that of harmonisation and the start of the 21st century with the formalisation of the management of risk: from a governing tool to a tool facilitating the transparency of communication, the various presentations show us how this new industrial concept will help us to master not only the conception of new medicines but also industrialisation, production, distribution and delivery to the patients. The management of risk when brought about through a structured process brings with it a new mindset, without to revolutionize our basics, and allows other principles to be retained such as the principle of precaution which keeps its rightful place concerning public health against still unknown risks. Health does not have a price but it does have a cost: although the management of risk is a new concept that gives us an improved command and increased efficiency, do not forget to apply practical common sense based on existing knowledge and when judging, discern the relevance of the management of risk.